Podcasts about biosimilars

2026 is the year of a major wave of pharmaceutical patent expirations, with numerous blockbuster drugs – spanning diabetes, immunology, cardiovascular, oncology, and other therapeutic areas – on the verge of losing market exclusivity. In a new pharmaphorum podcast, web editor Nicole Raleigh speaks with Rebecca Guntern, chief commercial officer at Sandoz, for a conversation on the ‘golden decade' for generics and biosimilars as so many blockbuster drugs come off patent. Guntern discusses why the current wave of blockbuster biologics losing exclusivity is so significant for patient access and healthcare budgets, and the conversation also touches upon policy and regulatory changes still needed in order to unlock the full potential of biosimilars, as well as what should be expected from the next generation of biosimilars. You can listen to episode 263 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it – and subscribe to the rest of the series – on Apple Podcasts, Spotify, Overcast, Pocket Casts, Podbean, and pretty much wherever else you download your other podcasts from.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements shaping the landscape of our industry. As technology continues to redefine traditional paradigms, the collaboration between Pfizer and Chai Discovery exemplifies this trend. By harnessing artificial intelligence, particularly through custom models like Chai-3, this partnership aims to revolutionize drug discovery. The integration of AI promises not only to accelerate the identification of biologics and antibodies but also to optimize resource allocation in research and development. Such technological integration could pave the way for an enhanced pipeline of innovative treatments, marking a transformative shift in how therapeutic candidates are developed. In the realm of regulatory developments, Lupin's Ranluspec has recently received FDA approval as an interchangeable biosimilar targeting VEGF-A for various retinal conditions. This move underscores the importance of biosimilars in providing cost-effective alternatives to expensive biologics, thereby expanding patient access to essential treatments for conditions like macular degeneration. Additionally, the MHRA's marketing authorization for Aujemflu, an adjuvanted trivalent influenza vaccine for adults aged 50 and over, reflects ongoing efforts to bolster protection against infectious diseases among vulnerable populations. Clinical trial advancements continue to highlight significant progress in therapeutic development. Otsuka Pharmaceuticals' Phase 3 data on Voyxact has shown promising stabilization of kidney function in patients with Immunoglobulin A nephropathy. This protein therapy targets autoimmune pathways, offering new hope for managing this chronic kidney condition. Similarly, Autobahn Therapeutics' Elunetirom has advanced to a pivotal trial following Phase 2 success in treating bipolar depression. This showcases the potential of small molecule therapies targeting thyroid hormone receptors. Meanwhile, Hikma Pharmaceuticals' victory in a landmark patent case regarding skinny labels marks an important development in pharmaceutical intellectual property rights. The unanimous Supreme Court ruling against Amarin supports the legitimacy of using skinny labels to market generic versions of drugs for non-patented indications. This decision could enhance market competition and drive down healthcare costs, setting a precedent for future intellectual property disputes. On the business front, strategic partnerships and mergers continue to shape industry dynamics. Gilead Sciences' acquisition of Ouro Medicines for $1.675 billion strengthens its autoimmune inflammation pipeline. This transaction exemplifies how major deals are reshaping therapeutic portfolios in response to growing demand for treatments targeting rare diseases. Financially, Solix Pharmaceuticals' success in raising $71 million to advance its siRNA pipeline across multiple therapeutic areas demonstrates investor confidence in RNA-based therapeutics as a promising frontier for innovative treatments. Conversely, challenges persist as evidenced by Takeda's $2.5 billion legal provision over an antitrust case related to Amitiza, underscoring ongoing financial risks associated with litigation in the pharmaceutical sector. Corporate restructuring also signals shifts within the industry landscape. Fulcrum Therapeutics' decision to lay off 85% of its workforce following the discontinuation of its sickle cell disease candidate highlights the volatility and high stakes inherent in drug development. Overall, these developments illustrate a dynamic landscape where scientific innovation is propelled by AI-driven approaches and strategic collaborations while regulatory victories and financial maneuvers shape market dynamics. These trends have profound implications for patient care by potentially accelerating the availability of novel therapies and fostering a competitive environment that drives down costs. As we look ahead, stakeholders must navigate these complexities effectively to harness opportunities and address challenges within this rapidly evolving industry landscape. The ability to adapt and capitalize on emerging trends will be crucial as these sectors continue to evolve, ultimately enhancing patient care and advancing therapeutic frontiers globally. Thank you for joining us today on Pharma Daily; stay tuned for more insights into the ever-changing world of pharmaceuticals and biotech.Support the show

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What do patients want to know about biosimilars? Credit available for this activity expires: 5/13/2027 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/1003363?ecd=bdc_podcast_libsyn_mscpedu

A mixed bag on Dalal Street! SBI's standalone profit hit ₹19,684 crore, but the stock faced pressure after missing analyst estimates. Join us as we break down the banking giant's Q4 scorecard and Biocon's ambitious roadmap for North America. We discuss the potential of Biocon's GLP-1 portfolio in FY27 and what the "Biosimilars" growth means for your healthcare holdings. Get the expert take here.

A mixed bag on Dalal Street! SBI's standalone profit hit ₹19,684 crore, but the stock faced pressure after missing analyst estimates. Join us as we break down the banking giant's Q4 scorecard and Biocon's ambitious roadmap for North America. We discuss the potential of Biocon's GLP-1 portfolio in FY27 and what the "Biosimilars" growth means for your healthcare holdings. Get the expert take here.

A mixed bag on Dalal Street! SBI's standalone profit hit ₹19,684 crore, but the stock faced pressure after missing analyst estimates. Join us as we break down the banking giant's Q4 scorecard and Biocon's ambitious roadmap for North America. We discuss the potential of Biocon's GLP-1 portfolio in FY27 and what the "Biosimilars" growth means for your healthcare holdings. Get the expert take here.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of significant updates that highlight the dynamic nature of our industry, driven by cutting-edge science, regulatory evolution, and strategic business innovations. The pharmaceutical landscape is ever-shifting, with recent developments underscoring this fluidity. Pfizer and Arvinas have secured early FDA approval for their breast cancer drug, Veppanu. This move signals the FDA's growing inclination to fast-track promising therapies, particularly in areas with high unmet needs. Interestingly, Pfizer and Arvinas are opting not to commercialize Veppanu independently and are instead seeking a partner. This decision reflects a broader industry trend where biopharmaceutical companies leverage partnerships to maximize the reach and impact of their therapies. Such strategies are becoming increasingly common as companies navigate complex market dynamics. Legal and healthcare domains intersected dramatically when the U.S. Supreme Court temporarily restored online access to the abortion pill mifepristone. This decision underscores the profound influence of legal rulings on healthcare access and distribution channels within the pharmaceutical sphere in the United States. It's a poignant reminder of how regulatory decisions can ripple through healthcare systems, affecting both providers and patients. Meanwhile, Samsung Biologics faces significant financial repercussions—estimated at $102 million—due to an ongoing union strike. This situation reveals vulnerabilities within contract development and manufacturing organizations (CDMOs) regarding labor relations, emphasizing the need for robust operational strategies to maintain production continuity. In a move that underscores its commitment to biologics manufacturing, Amgen announced a $300 million investment in Puerto Rico. This expansion aligns with growing global demand for biologics and biosimilars and highlights Puerto Rico's strategic importance as a pharmaceutical manufacturing hub, thanks to its favorable business environment and skilled workforce. On a different front, Novartis is optimizing its workforce by implementing additional job cuts at its U.S. headquarters. These adjustments are part of a larger multiyear plan aimed at streamlining operations and reallocating resources towards areas with higher growth potential within its portfolio. The potential resurgence of psychedelics is gaining traction, partly fueled by political support from figures like Donald Trump. The regulatory landscape for psychedelics remains complex, with discussions focusing on their therapeutic potential versus societal acceptance and legitimacy concerns. In the competitive weight-loss drug market, Novo Nordisk's Wegovy pill is currently outperforming Eli Lilly's Foundayo in prescription trends. This rivalry highlights the dynamic nature of the GLP-1 receptor agonist segment—a market experiencing rapid growth due to increasing attention on obesity management as a critical public health issue. Deloitte's latest analysis reveals an intriguing shift: obesity drugs have now overtaken oncology as the leading contributor to late-stage pipeline value for the first time in 16 years. This transition underscores a growing recognition of obesity as an essential therapeutic area with significant market potential, driven by advances in drug efficacy and heightened patient demand. Celcuity has reached a pivotal milestone in breast cancer treatment development with its Phase 3 trial success of a pan-PI3K/mTOR inhibitor against Novartis' Piqray. Achieving primary endpoints positions Celcuity favorably for FDA review, further highlighting continuous innovation within oncology research. UCB's acquisition of Candid Therapeutics for $2 billion exemplifies intensified competition Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a fascinating array of industry shifts and scientific breakthroughs that are shaping the future of medicine and patient care. Sun Pharma's acquisition of Organon for $11.75 billion is making waves as it marks a significant expansion for the Indian pharmaceutical giant into international markets. This deal not only amplifies Sun Pharma's footprint but also integrates Organon's strong focus on women's health and biosimilars into its portfolio. It's a strategic move that underscores the increasing trend of cross-border mergers as companies seek to diversify and enhance their global presence. As the largest-ever overseas acquisition by an Indian firm, this transaction is emblematic of the growing importance of global consolidation in the pharma industry. Meanwhile, Astellas Pharma faces a mixed fiscal outlook with its prostate cancer drug Xtandi. While Xtandi experienced a modest sales increase in 2025, a projected decline for 2026 has prompted Astellas to pivot towards developing new medicines. This highlights the critical dependence on innovation within the industry to sustain growth, especially as competition intensifies. In the realm of ATTR amyloidosis treatments, Pfizer has reached a settlement with two generic manufacturers over its drug Vyndamax. This resolution is crucial in stabilizing the market amidst rising generic competition, which can significantly influence pricing and market dynamics. Such settlements are an integral part of maintaining competitive positioning in crowded therapeutic spaces. Ligand Pharmaceuticals' strategic purchase of XOMA for $739 million signals a broader trend of consolidation among biotech royalty aggregators. This acquisition aligns with Ligand's strategy to augment its portfolio through mergers and acquisitions—a recurring theme as biotech companies strive to streamline operations and expand their competitive edge. The competition within the oral GLP-1 market is intensifying, particularly with Eli Lilly's delayed launch of Foundayo inadvertently benefiting Novo Nordisk's market position. This rivalry underscores the fierce race to dominate the lucrative obesity management sector, highlighting how pivotal timing can be in gaining market share. The FDA's recent allocation of national priority vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics marks a significant regulatory shift towards embracing psychedelic therapies. These vouchers could expedite development timelines, thereby accelerating patient access to novel treatments that have traditionally been underexplored. Thermo Fisher Scientific's robust start to 2026 showcases how strategic acquisitions like that of Clario can drive growth. This reflects broader industry trends where biopharma companies leverage technological advancements to enhance capabilities in clinical trial support and data management. In gene editing news, Intellia Therapeutics is advancing towards FDA approval for its in vivo CRISPR therapy following successful Phase 3 trials. This progress heralds a new era for gene editing technologies in treating genetic disorders, underscoring their potential to revolutionize therapeutic approaches. Eli Lilly continues its aggressive acquisition strategy by purchasing Ajax Therapeutics for $2.3 billion. This acquisition focuses on next-generation JAK inhibitors for myelofibrosis, aligning with Lilly's broader goal to diversify its pipeline and maintain its leadership in innovative therapeutics. Recent studies have also shed light on how an endoscopic procedure used in Europe can aid patients on Eli Lilly's tirzepatide in maintaining weight loss post-treatment. This finding could significantly impact long-term obesity management strategies, offering new insights into sustainaSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of pivotal events shaping the industry. Starting with Amneal Pharmaceuticals' strategic acquisition of Kashiv Biosciences for $1.1 billion, this move highlights what many are calling the "golden era" for biosimilars. These cost-effective alternatives to branded biologics are becoming increasingly crucial in expanding access to essential therapies. Amneal's acquisition underscores a strategic positioning to enhance its portfolio and market presence, reflecting a broader trend towards embracing biosimilars to potentially reduce healthcare costs. In another significant development, Merck has received FDA approval for its novel HIV treatment pill, Idvynso. This once-daily combination offers a new mechanism of action, reinforcing Merck's position in the HIV market while emphasizing the industry's ongoing innovation aimed at improving patient adherence and outcomes with simpler dosing regimens. Concurrently, Merck's partnership with Google in a billion-dollar enterprise deal underscores a growing trend: the integration of artificial intelligence into drug discovery and development processes. This alliance is part of an industry-wide movement towards leveraging AI to streamline R&D efforts, boost efficiency, and accelerate the time-to-market for new therapies. The competitive landscape for oral GLP-1 weight-loss drugs is heating up as Eli Lilly and Novo Nordisk vie for dominance. Monitoring prescription trends through advanced analytics tools provides insights into market dynamics, shaping future strategies for these companies. Proposed Medicare coverage for GLP-1 receptor agonists faced a setback with major insurers expressing hesitation to participate, which could affect access and affordability of these therapies used in managing type 2 diabetes and obesity. Meanwhile, Kyverna Therapeutics is making strides with CAR-T therapies for autoimmune diseases, presenting comprehensive data from its registrational trial of MIV-CEL for Stiff Person Syndrome. This could lead to the first FDA-approved CAR-T therapy in this domain, illustrating CAR-T's expanding applications beyond oncology and heralding a new era in personalized medicine approaches to autoimmune conditions. Samsung Biologics reports significant revenue growth amidst labor union challenges, highlighting its robust operational capabilities in biopharmaceutical manufacturing. This growth underscores the increasing demand for biologic drugs and the essential role of contract development and manufacturing organizations (CDMOs) in global supply chains. On the regulatory front, Novartis has faced setbacks with its anticoagulant Abelacimab after halting Phase 3 trials due to failure to outperform existing therapies like Eliquis. This highlights the inherent challenges in drug development where clinical efficacy must be clearly demonstrated. Meanwhile, ongoing discussions between regulatory bodies like the FDA and industry stakeholders are vital for aligning expectations with innovative R&D practices. The FDA has authorized clinical trials for ibogaine, a psychoactive substance with potential benefits in treating addiction and mental health disorders. This marks a pivotal moment in psychedelic research that could reshape treatment paradigms for neuropsychiatric conditions if safety standards are maintained. In vaccine news, Moderna has achieved European Union approval for its combination flu/COVID-19 vaccine—a significant stride given global pandemic preparedness efforts. However, its U.S. application remains stalled amid uncertainties about resubmission timelines. Eli Lilly's decision to exit its partnership with Rigel Pharmaceuticals reflects challenges in developing RIPK1 inhibitors for central nervous system disorders. This underscoreSupport the show

Drawing from Employers Health's book of business, Jack Sullivan and Hannah Whitesel sit down with host Mike Stull to examine today's key drivers of pharmacy spend, including GLP-1s, biosimilars and autoimmune conditions. Watch or listen to Benefits Bites and Health Care Headlines.  Register for upcoming Employers Health webinars or watch on demand at Events - Employers Health. Sign up for our monthly newsletter here. Find additional helpful benefits strategies and resources at Articles | Employers Health.

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes. Dr. Niazi offers a behind the scene look at the way FDA policy gets made, and unmade, and his own role in key regulatory changes, and legislation such as the Biologics Price Competition and Innovations Act (BPCIA), and the Inflation Reduction Act (IRA). We also discuss Dr. Niazi's current company, RNA Therapeutics, and his quest to make new drug modalities accessible to patients around the world.     This episode of the Business of Biotech is brought to you by Cytiva. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.  Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Your patient asks, "Will switching to a biosimilar make my disease worse?" Learn how to confidently address their concerns.  Credit available for this activity expires: 4/7/27 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/1003282?ecd=bdc_podcast_libsyn_mscpedu

On this episode of the Astonishing Healthcare Podcast, we sit down with return guest Bridget Mulvenna, Vice President of National Business Development at Judi Health, to break down the biggest pharmacy drivers of 2026. Bridget offers insights into how plan sponsors and benefits brokers and consultants can strategically evaluate pharmacy benefit managers (PBMs) by looking beyond unit costs and focusing on drug mix - formulary decisions and the shift to biosimilars, prior authorization approval rates, the generic dispensing rate (GDR), and much more.The discussion covers the growing need to understand what challenges employer plan sponsors face, and why bringing a consultative approach to the table to help solve them is so important. How will moving to a biosimilar-first approach lower net drug costs for plan sponsors? How can a plan cover GLP-1s given their evolution and greater price transparency, expanding clinical indications, and direct-to-plan pricing models? And of course, Bridget shares her views on the sudden acceleration of state and federal PBM reform. As new legislation forces the industry to adapt, plan sponsors must seek forward-thinking platforms already aligned with the changes to provide better pricing and care for members.HighlightsBridget emphasizes the financial advantages of adopting a biosimilar-first approach, which can significantly lower net drug costs for plan sponsors despite smaller rebate checks.GLP-1s are transformative medications - price transparency, expanding clinical indications, and direct-to-plan pricing models will influence future plan designs.Evaluating PBMs beyond unit costs is critical: formulary management, prior authorizations, and other clinical programs have the greatest impact on total pharmacy spend.The rapid acceleration of state and federal PBM reform is astonishing, and alignment with future proof organizations is essential, because there's more to come.Related Content6 recommendations for PBM procurement and Rx benefits optimizationAH102 - PBM Reform Update: Health Policy Changes Slowly, Until it Doesn't, with Lloyd FioriniReplay - PMPM vs Clinical Guarantees: A Pharmacist and an Actuary Explain How to Create Predictability Around Pharmacy SpendAH064 - Empowering Plan Sponsors: Data Access & Analysis, with Bridget MulvennaFor more information about Judi Health and this episode, please visit Judi Health - Insights.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore the latest news and trends shaping this dynamic industry.Significant strides have been made recently, particularly with the FDA's approval of J&J and Protagonist Therapeutics' novel psoriasis medication, Icotyde. This once-daily oral treatment could disrupt a market dominated by injectable therapies. The convenience of oral administration is likely to improve patient compliance and drive substantial sales, marking a pivotal moment in psoriasis treatment. The Phase 3 ICONIC trial demonstrated substantial efficacy over existing treatments like Bristol Myers Squibb's Sotyktu. This trend towards more patient-friendly options is indicative of a broader industry shift and signifies Protagonist's entry into competitive immunology markets.Turning to biosimilars, Sandoz has expanded its partnership with Samsung Bioepis to commercialize up to five biosimilars, including a version of Takeda's Entyvio. This collaboration highlights the industry's growing reliance on biosimilars as affordable alternatives to branded biologics. Amidst pricing pressures and a global demand for accessible medications, such strategies are becoming increasingly vital.In an ambitious venture, TerraPower Isotopes, backed by the Gates Foundation, is investing $450 million in a plant for producing actinium-225, a rare isotope used in radiopharmaceuticals. This move positions TerraPower as a leader in supplying crucial ingredients for targeted cancer therapies—an area that promises advancements in precision medicine by offering targeted treatments with fewer side effects.Regulatory landscapes are evolving too, with the FDA and NIH committing $150 million towards alternatives to animal testing in drug development. This initiative emphasizes ethical scientific practices and leverages innovative technologies like organ-on-chip systems. Such regulatory support is essential for speeding up drug development while ensuring safety standards remain high.Stem cell therapy also sees promising developments with Aspen Neuroscience's treatment for Parkinson's disease. After one year, all treated patients showed symptom improvement, paving the way for pivotal Phase 3 trials. These results underscore the transformative potential of regenerative medicine in tackling neurodegenerative disorders.As the industry evolves, it faces challenges such as looming patent expirations and intensified competition. These pressures are prompting companies to innovate and reconsider strategies for existing product lines. In response to these challenges, strategic realignments are becoming more common.Meanwhile, Indiana's plan to create 100,000 jobs through a $1 billion strategy highlights regional efforts to establish hubs for life sciences innovation, illustrating the broader economic impact of the biopharma sector.In parallel news, Xaira Therapeutics has raised an impressive $1 billion to leverage AI for drug discovery in inflammatory and immunological research. This underscores growing reliance on AI technologies to accelerate drug development timelines. Crossbow Therapeutics reached a significant milestone by securing $77 million in Series B funding to advance its T-cell engager technology—a promising approach in immuno-oncology that harnesses the immune system against cancer cells.Despite these advancements, economic pressures continue to challenge some companies. Layoffs at Gossamer Bio and Bicycle Therapeutics highlight sector volatility and the need for strategic adaptability. Corporate governance remains under scrutiny as Moderna's CEO compensation package reveals executive priorities amidst revenue shortfalls. Meanwhile, GSK faces criticism over its management practices concerning Flovent, which raises ethical concerns about pricing strategies.In cardiovascular care, Support the show

What does it take to get a life-changing medicine from regulatory approval to the patient who needs it? Isabell Remus, Global Head of Biosimilars at Sandoz, reveals why being approved and affordable isn't enough – and how the biosimilar industry learned that trust and education must come before market access. With $320 billion in biologic medicines losing patent exclusivity over the next decade, she explores the strategic complexities of launching at the exact moment a patent expires, the role of diversified manufacturing in strengthening supply chain resilience, and why expanding access to essential medications requires both purpose and commercial viability. An eye-opening conversation on making affordable healthcare a reality for millions of patients worldwide.

On this week's This Week in Pharmacy (TWIRx), we explore how innovation, technology, and emerging therapies are reshaping pharmacy practice. From the growing influence of AI in medical information research, to the next generation of pharmacy management systems, and the expanding role of cell and gene therapies, this episode brings together industry leaders to discuss what's next for pharmacy. Special thanks to this week's sponsors Cardinal Health, Independent Pharmacy Cooperative (IPC), and Nested Knowledge for supporting the podcast. Segment 1 – AI & the Future of Medical Information with Nested Knowledge Nested Knowledge returns to TWIRx as we welcome back Keith Kallmes, Co-Founder of Nested Knowledge, for an update on how artificial intelligence is transforming the way healthcare professionals access and interpret medical information. Keith explains how AI-powered tools are improving evidence synthesis, systematic literature reviews, and clinical decision support, helping researchers and clinicians navigate the growing volume of medical literature while enabling faster, more reliable insights. Segment 2 – The Evolution of Pharmacy Management Systems with Outcomes Next, we're joined by Lou Ann Myers from Outcomes to discuss how pharmacy management systems are evolving beyond traditional dispensing. Modern pharmacies require integrated technology connecting billing, treatment planning, clinical tracking, inventory management, and revenue-generating services. Lou Ann shares why these systems must support both clinical services and business sustainability as pharmacies expand into value-based care and new service models. Segment 3 – Emerging Therapies with Cardinal Health In our final segment, we welcome Dr. Fran Gregory, PharmD, Vice President of Emerging Therapies (Cell & Gene, Biosimilars) at Cardinal Health, to discuss one of the most transformative areas in healthcare. Dr. Gregory explores the growing impact of cell and gene therapies and biosimilars, and what these innovations mean for pharmacists, health systems, and specialty pharmacy providers as the industry prepares for new challenges in distribution, access, and reimbursement. About TWIRx (This Week in Pharmacy) TWIRx is the flagship news and commentary podcast from the Pharmacy Podcast Network, delivering weekly insights on the business, technology, and policy shaping the pharmacy profession.

Editor's Summary by Linda Brubaker, MD, and Preeti Malani, MD, MSJ, Deputy Editors of JAMA, the Journal of the American Medical Association, for articles published from March 7-13, 2026.

Hear leading dermatologist Dr. E. James Song and patient advocate Ana Rinck share their perspectives on the use of biosimilars to manage psoriasis and psoriatic arthritis. The use of biosimilars is growing with 24 currently on the market and more on the way for the treatment of psoriasis and psoriatic arthritis. What does this mean for you? Find out as we explore the use of biosimilars, the impact of interchangeability, what it's like switching to a biosimilar, and what questions to ask your health care provider with leading dermatologist and NPF Medical Board member Dr. E. James Song, Director of Clinical Research at Frontier Dermatology Partners, and patient advocate Ana Rinck who currently uses a biosimilar to treat her psoriasis and psoriatic arthritis.   The intent of this episode is to offer an update on the use of biosimilars and to hear the experience of those who have used biosimilars to manage psoriatic disease. This episode is sponsored by Organon. Timestamps: (0:00) Intro to Psoriasis Uncovered and guest welcome to dermatologist Dr. E. James Song, Director of Clinical Research and Co-Chief Medical Officer, Frontier Dermatology, and patient advocate Ana Rinck, who presents her experience with using a biosimilar to treat psoriasis and psoriatic arthritis.  (0:58) Definition of what is a biosimilar in comparison to a biologic which is also referred to as the original bio-originator or reference product.   (3:10) What biosimilars are available and how they are used. (4:35) The term interchangeable and what it means for use of a biosimilar. (5:46) Ana's diagnosis to treatment options starting with use of topicals to ultimately use of a biosimilar.  (7:57) Treatment discussion and choices when faced with diminishing effectiveness within a class of medications. Should a biosimilar be considered as an option?                                                                                                                                                                (9:50) Questions to consider when there's a change in treatment. (10:57) FDA announcement to simplify the development process for biosimilars and what that means for the future use of biosimilars. (13:55) What to consider when thinking of a biosimilar as a treatment option and where to find help when needed.     (14:53) The hope and equity of access that biosimilars represent is here for the appropriate individual. Key Takeaways: ·       A biosimilar is an FDA-approved biologic product that behaves and functions like a brand biologic treatment which is also called the reference product or bio-originator. There are no clinically meaningful differences between biosimilars and their reference product.  ·       The FDA has approved several biosimilars for the treatment of psoriasis and psoriatic arthritis. Some have been identified as interchangeable which means a biosimilar could be substituted for a reference product without a health care provider's approval pending state legislative rules.    ·       Don't be afraid to ask questions or access resources to assist with preparing for a medication change should that change be initiated either by yourself, your healthcare provider, or your health insurance company.    Guest Bios:   E. James Song, M.D. is a nationally recognized dermatologist and clinical researcher who is also a Clinical Instructor at the University of Washington. Dr Song is recognized as a key opinion leader in treating psoriasis and atopic dermatitis. He is actively involved in the development of new therapies for dermatologic disease and has firsthand experience with treatments before they come to market. Dr. Song has been published extensively in peer review journals and regularly participates in meetings both as a lecturer and attendee.  He is also a Medical Board member of the National Psoriasis Foundation. He believes that the best health outcomes come from shared decision making between the patient and physician. Dr. Song strives to help patients understand not only their condition, but all their treatment options.  Ana Rinck is a patient advocate and volunteer for the National Psoriasis Foundation. She developed psoriasis in 2009 following symptoms she noticed for a few years which proved to be challenging to diagnose. She managed for many years on topicals and intralesional injections. In 2018 she was diagnosed with psoriatic arthritis and started use of a biologic realizing she needed to protect her joints from further damage. She now uses a biosimilar to manage her psoriatic disease. Ana owns her own private consulting business and is an Operations and Project Manager.  Resources: -Learn more about biosimilars, interchangeability, and state substitution rules.   -Armstrong A, Callis Duffin K, Feldman S, Glick B, Kalb R, Reddy S, Schwartzman S, Yamauchi P, Calabrese C, Cordoro K, Desai S, Gladman D, Han G, Hawkes JE, Hsu S, Kircik L, Koo J, Kreuger GG, Lebwohl M, Leonardi C, Lewitt GM, Liao W, Liu C, Markenson J, Merola JF, Orbai A, Prussick R, Richardson V, Soung J, Van Voorhees AS, Wallace E, Weinberg J, Wine Lee L, Harris J, Koons S, Howard L. Position Statement on the Use of Biosimilars for Psoriasis and Psoriatic Arthritis. National Psoriasis Foundation Medical Board. 2023. -If you need help finding a dermatologist near you contact the NPF's Patient Navigation Center for assistance.   

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements and strategic shifts currently shaping the landscape of these industries.To start, let's discuss a remarkable development in therapeutic treatments. UCB's Bimzelx has demonstrated superior efficacy over AbbVie's Skyrizi in treating psoriatic arthritis, as revealed by a head-to-head phase 3b clinical trial. This finding not only extends UCB's winning streak in psoriasis treatment but also positions Bimzelx as a competitive alternative in the immunology sector. The implications of this are profound, potentially influencing prescribing patterns and improving patient outcomes by offering an effective alternative for those with psoriatic conditions.In manufacturing news, Eli Lilly is making waves with its substantial $3 billion investment aimed at enhancing the global supply chain for Orforglipron, their oral GLP-1 receptor agonist. This move highlights a growing demand for GLP-1 therapies, crucial for managing type 2 diabetes and obesity. The strategic focus on oral therapies reflects a broader industry trend towards improving patient compliance compared to injectable alternatives, underscoring the importance of such innovative treatments in addressing widespread health issues. Additionally, Eli Lilly's commitment to investing $500 million into South Korea's biopharmaceutical sector signals the country's rising status as a hub for biopharmaceutical innovation and development, likely fostering collaborations and expediting novel therapeutics' development.Economically, there's compelling evidence of the impact public funding has on scientific advancement. A recent report by United for Medical Research revealed that National Institutes of Health (NIH) grants generated $94.15 billion in economic activity in 2025, supporting nearly 391,000 jobs. This underscores the dual role of public funding in advancing biomedical research and stimulating economic growth.On the regulatory front, Sandoz is making a strategic move to establish a standalone unit dedicated to biosimilars. As we enter what Sandoz describes as a 'golden decade' of patent expirations, this realignment reflects anticipation of expansion opportunities within the biosimilars market. Such preparations suggest increased competition and potentially more affordable biologic therapy options as major drugs lose patent protection.Technological advancements are further shaping industry operations. BD's partnership with Sinteco to automate pharmacy logistics in Europe is part of a broader push to integrate robotics into healthcare processes. This aligns with digital transformation trends across the sector aimed at improving efficiency and reducing human error. Meanwhile, Medtronic's former diabetes division Minimed has achieved European approval for its 780G insulin pump system, which integrates with Abbott's continuous glucose monitor (CGM). This approval is noteworthy for enhancing diabetes management through automation of insulin delivery based on real-time glucose monitoring, representing a significant step forward in closed-loop systems.A notable technological initiative comes from ARPA-H with their program focused on developing wearable biosensors under the Delphi initiative. These sensors aim to enhance personal health monitoring capabilities across various devices, aligning with trends towards personalized medicine and digital health technologies.Despite these positive strides, challenges persist. The closure of F5 Therapeutics highlights early-stage biotech struggles amid competitive pressures. Regulatory setbacks also continue to pose challenges; Novo Nordisk recently received an FDA warning letter following inspection issues at its U.S. headquarters.Collectively, these trends reflect an industry resiliently pursuSupport the show

John is joined by Jonathan Graham, Executive Vice President and General Counsel and Secretary of Amgen, one of the world's largest biotech companies and one of the pioneers of the industry. They discuss in-house legal leadership in major biotech companies and how science, intellectual property, and regulation shape strategy. Jonathan began his practice clerking for the Ninth Circuit Court of Appeals, then became a litigator for a large firm. Later, his career shifted in-house. He believes that litigation training develops useful skills, including rapid issue spotting across unfamiliar domains, crisp written and oral advocacy, and an ability to understand stakeholders' incentives.The biotech industry is unusually purpose-driven because the output is medicine that can extend life and restore quality of life. That mission creates urgency across functions, as delays can mean patients wait longer for needed therapies. The sector is also highly regulated and fast-moving, which elevates the importance of legal teams that operate as strategic partners rather than as a “department of no.”Intellectual property is the economic lifeblood of biological drug development. Bringing a molecule to market often costs billions of dollars and requires years of lab work, clinical trials, and manufacturing scale-up. Without enforceable patents, competitors could free ride, undermining investment incentives. This reality drives frequent, high-stakes patent disputes that can be hard to settle because exclusivity is enormously valuable.Patent doctrines often lag behind technology, forcing courts to fit new technologies into older legal frameworks. Artificial intelligence is potentially a powerful tool for discovery and analysis of molecules, but not a substitute for wet-lab validation or human inventorship. Regulators still require clinical evidence before any medicine is approved and likely will for the foreseeable future.Biosimilars are currently a booming market with many parallels to generic drugs. A company may participate in the market as both innovator and biosimilar supplier by leveraging its research and manufacturing capabilities. Finally, government-driven drug pricing controls may slow innovation over time, even though scientific progress and therapeutic potential remain strong.Podcast Link: Law-disrupted.fmHost: John B. Quinn Producer: Alexis HydeMusic and Editing by: Alexander Rossi

In der Pharmaindustrie laufen in den nächsten 10 Jahren Patente im Wert von über 650 Mrd. US-Dollar aus. Profiteure sind Hersteller von Nachahmer-Produkten wie Sandoz. Laut der Produkte-Leiterin Rebecca Guntern hat Sandoz mit 27 Biosimilars eine führende Pipeline in diesem margenstarken Segment. SMI -0.1%

Clear communication builds trust in biosimilars.  Credit available for this activity expires: 2/19/27 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/1003245?ecd=bdc_podcast_libsyn_mscpedu

How early in process development should you address glycosylation? This episode presents the case for co-optimizing glycan profiles with productivity from initial process characterization. Deferring glycosylation characterization until after titer targets are met introduces risk: quality attribute gaps discovered late in development force process re-optimization, extended timelines, and potential cell line reselection. Media supplementation enables earlier intervention—tuning glycan distribution as a process parameter from the beginning of cell line and media development rather than as a remediation strategy.David Brühlmann outlines the experimental protocol for validating raffinose supplementation, including decision criteria for proceeding or terminating at each development stage. The discussion addresses process design space requirements, analytical monitoring strategy, and the experimental variables that determine when media-based glycan tuning is appropriate versus when alternative approaches are needed.Highlights from the episode:When to use (and not use) raffinose in your development program, including limitations and effectiveness windows (00:30)Essential protocol: three experiments over eight weeks to validate raffinose for your process, with clear go/no-go criteria (04:09)Why individualized mannose tracking (Man5, Man6, Man7, Man8) is crucial for meaningful results (01:06)Managing osmolality: why it matters and how to control it in your experiment (04:36)Advice on scaling up: moving from small-scale screens to benchtop bioreactors and stress-testing your process (07:48)Three key mistakes to avoid when implementing raffinose, including lessons from analytical oversight, incomplete design mapping, and feed interference (09:08)Integrating glycosylation as a core part of process design, not just a secondary consideration after titer optimization (13:10)Strategic insight:Sequential optimization of productivity followed by glycosylation introduces development risk: quality attribute deviations discovered after process lockdown require costly re-optimization cycles. Parallel development of titer and glycan specifications from initial cell line characterization reduces this risk by establishing feasible operating windows early in the development timeline.Are you planning your next recombinant protein scale-up? Hear how David's rule-of-three protocol and battle-tested lessons can help you optimize faster and avoid painful late-stage surprises.Resources: Journal of Biotechnology, 2017, volume 252, pages 32 to 42Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

When your biosimilar analytical data shows 1.4% high mannose against a 6% reference product specification, you face limited options: process temperature shifts that compromise titer, kifunensine supplementation that requires extensive regulatory justification, or 12-18 months to reclone and revalidate. Media supplementation offers an alternative pathway—tuning glycan profiles through formulation adjustments rather than cell line or process re-engineering.In this episode, David Brühlmann presents the experimental development of a media supplementation strategy that achieved 2.8-fold increases in high mannose glycans across multiple CHO cell lines. Drawing from research published in the Journal of Biotechnology (2017, 252:32-42), the discussion covers the mechanism of raffinose-mediated glycan processing arrest, the experimental variables that initially obscured the effect, and the process development considerations for implementing media-based glycan tuning.The episode examines N-glycan biosynthesis in CHO cells, regulatory comparability requirements for biosimilar glycosylation profiles, and the experimental framework for evaluating media supplementation as a glycan control strategy.Highlights from the episode:The unexpected link between dietary raffinose and reduced athletic performance, and its connection to bioprocessing (01:11)A clear primer on the importance of glycosylation for biosimilar drugs and regulatory approval (02:43)Common challenges when glycan profiles don't match reference products, and why high mannose glycans matter (04:19)A review of industry strategies (temperature shifts, enzyme inhibitors, cell line reengineering) and their pitfalls (05:33)Mechanistic insights into how raffinose alters glycan processing in CHO cells (07:05)Key experimental findings on raffinose concentration, osmolality control, and practical lab troubleshooting (09:48)Application stories and regulatory considerations for implementing raffinose-based media adjustments (13:47)Closing thoughts on process optimization, regulatory impact, and what to expect in Part 2 (15:11)Strategic insight:Implementing raffinose as a media supplement is straightforward, regulatory-friendly, and cost-effective. It does not involve genetic engineering or enzyme inhibitors and is easily sourced as a GMP-grade material. For programs approaching submission with glycan comparability gaps, media-based tuning offers a process optimization pathway that maintains existing cell lines and manufacturing platforms while addressing critical quality attribute specifications.Listen to this episode of the Smart Biotech Scientist Podcast to learn David's best strategies for rapid, regulatory-friendly glycosylation control.If you want to transform your glycoengineering workflow, keep an eye (and ear) out for the next episode of the Smart Biotech Scientist Podcast. Your path to regulatory success might be as simple as a pinch of raffinose.Resources: Journal of Biotechnology, 2017, volume 252, pages 32 to 42Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

With the number of biosimilar products steadily increasing, pharmacists play a central role in ensuring their appropriate use in inflammatory conditions. This episode highlights approval pathways, interchangeability, and real-world challenges pharmacists may face when integrating biosimilars into care plans. You will walk away better prepared to support prescribers, counsel patients, and contribute to cost-effective, evidence-informed therapy decisions.HOSTRachel Maynard, PharmDGameChangers Podcast Host and Clinical Editor, CEimpactLead Editor, PyrlsGUESTReemal Zaheer, PharmD, CSPPharmacistJohns Hopkins Medicine Pharmacists, REDEEM YOUR CPE HERE!CPE is available to Health Mart franchise members onlyTo learn more about Health Mart, click here: https://join.healthmart.com/CPE INFORMATION Learning ObjectivesUpon successful completion of this knowledge-based activity, participants should be able to:1. Explain the role of biosimilars in the treatment of inflammatory conditions.2. Describe considerations for the pharmacist when evaluating or counseling on biosimilar therapies.Rachel Maynard and Reemal Zaheer have no relevant financial relationships with ineligible companies to disclose.0.075 CEU/0.75 HrUAN: 0107-0000-26-045-H01-PInitial release date: 2/2/2026Expiration date: 2/2/2027Additional CPE details can be found here.

With the number of biosimilar products steadily increasing, pharmacists play a central role in ensuring their appropriate use in inflammatory conditions. This episode highlights approval pathways, interchangeability, and real-world challenges pharmacists may face when integrating biosimilars into care plans. You will walk away better prepared to support prescribers, counsel patients, and contribute to cost-effective, evidence-informed therapy decisions.HOSTRachel Maynard, PharmDGameChangers Podcast Host and Clinical Editor, CEimpactLead Editor, PyrlsGUESTReemal Zaheer, PharmD, CSPPharmacistJohns Hopkins MedicineGAMECHANGERS CLINICAL UPDATE SERIESThe Clinical Update Series for Pharmacists delivers 52 expert-led podcast episodes and 30+ hours of clinically actionable continuing education, all for a one-time purchase of just $99—that's less than $3 per hour for high-impact learning you can apply immediately in practice. Click here to enroll. PRACTICE RESOURCEPurchase the Clinical Update Series or this course individually to receive the exclusive downloadable practice resource handout to use as a reference guide to the podcast. CPE REDEMPTIONThis course is accredited for continuing pharmacy education! Click the link below that applies to you to take the exam and evaluation:If you are already enrolled in this course, click here to redeem your credit. To purchase the Clinical Update Series and claim your CPE credit, click here or to purchase this course individually, click here.  CPE INFORMATIONLearning ObjectivesUpon successful completion of this knowledge-based activity, participants should be able to:1. Explain the role of biosimilars in the treatment of inflammatory conditions.2. Describe considerations for the pharmacist when evaluating or counseling on biosimilar therapies.Rachel Maynard and Reemal Zaheer have no relevant financial relationships with ineligible companies to disclose. 0.075 CEU/0.75 HrUAN: 0107-0000-26-045-H01-PInitial release date: 2/2/2026Expiration date: 2/2/2027Additional CPE details can be found here.Follow CEimpact on Social Media:LinkedInInstagram

For Episode 99 of Astonishing Healthcare, we welcome Hannan Allen, SVP of Consultant Relations to the company and show! The discussion builds on Episodes 90 and 93, with Jim Winkler of Business Group on Health and Susana Villegas Spillman, respectively, by explaining why "pharmacy benefit consultants have a really tough job right now" and tackling some timely questions, including how has the role of the benefits broker or consultant evolved? What's making the job so complex lately? And, are plan sponsors' primary needs changing? We cover these questions and many more - including who will win Super Bowl LX. - with Hannan, so if you're working in the pharmacy and health benefits space, you won't want to miss this one. Tune in to hear about:Biosimilars - the big opportunity and challenges PBMs have createdThe push for transparency, and what it means for consultantsHow to weigh price/cost, and why drug mix is so importantPrioritizing member care and programs that benefit membersThe opportunity cost of sticking with the status quo (is astonishing)Related ContentHow employers can take back control of unnecessary pharmacy spendingJudi Health Policy Pulse: 2025 Regulatory Roundup, the Push for PBM ReformReplay: PBM Procurement Decoded: Insights from a Pharmacist and an ActuaryHealth Benefits 101: Service Excellence & Scaling an Award-Winning Call Center ModelFor more information about Judi Health and this episode, please visit Judi Health - Insights.

In this episode of Bowel Sounds, hosts Dr. Peter Lu and Dr. Jenn Lee talk to Dr. Ross Maltz, pediatric gastroenterologist at Nationwide Children's Hospital and Associate Professor at The Ohio State University College of Medicine.  He is Director of the Very Early Onset Inflammatory Bowel Disease (VEOIBD) Program and Research Director of the Inflammatory Bowel Disease Center at Nationwide Children's.He provides a massive update on all things IBD medications, including discussing the latest on biosimilar medications, the medications we have available and their positioning, and new things in the pipeline.Dr. Maltz does not have any conflicts of interest to disclose.Learning objectivesUnderstand the safety and efficacy of biosimilar medications for children with IBD.Review the latest guidance on medications available for treatment of children with IBD.Discuss opportunities for advocacy to provide better access to IBD medications for children.Support the showThis episode may be eligible for CME credit! Once you have listened to the episode, click this link to claim your credit. Credit is available to NASPGHAN members (if you are not a member, you should probably sign up). And thank you to the NASPGHAN Professional Education Committee for their review!As always, the discussion, views, and recommendations in this podcast are the sole responsibility of the hosts and guests and are subject to change over time with advances in the field.Check out our merch website!Follow us on Bluesky, Twitter, Facebook and Instagram for all the latest news and upcoming episodes.Click here to support the show.

In this special 2025 U.S. Policy Highlights edition of the Vital Health Podcast, we look back at our most important discussions on Most Favored Nation (MFN) drug pricing and its knock-on effects for jobs, state budgets, and the generic supply chain. Over the past year, proposals to link U.S. prices to those in other countries have collided with inflation pressures, tariff debates, and reshoring efforts, creating new uncertainty for manufacturers, payers, and policymakers. In an environment where expectations about future returns are shifting, and the rules of the game are still being defined, this episode is designed as a year-end guide to what MFN-style policies could mean in practice and how to think about the tradeoffs. Throughout 2025, we our research on MFN-style reference pricing with a series of podcast episodes where host Duane Schulthess sat down with leaders across the generic, distribution, and policy landscape. In this highlights episode, we revisit several of those conversations: Kirsten Axelsen: Part D Shift, IRA Penalties, and Access Risks Patrick Kelly: Inside the Generic Supply Chain Squeeze John Murphy: Generics, Biosimilars, and U.S. Policy VT’s Grumpies (Harry Bowen, Joe Hammang) Talk MFN Key Topics: MFN Mechanics Explained: How tying U.S. prices to the lowest GDP-adjusted price in a reference basket translates into steep cuts for top-spend medicines in Medicare Parts B and D and shapes expectations across commercial and Medicaid contracts. Jobs, Earnings, & State Budgets: What our modeling suggests about potential impacts on employment, earnings, and tax revenue under MFN-style reference pricing, and how those effects concentrate in R&D-intensive regions and manufacturing hubs. Spillovers Into Medicaid, 340B, & ASP: Why MFN in Medicare does not stay in Medicare, how Medicaid best price and 340B ceilings pull discounts across programs, and what lower ASP add-ons could mean for hospital and community oncology margins. Generics, Shortages, & Tariffs: How razor-thin margins for sterile injectables and generic manufacturers interact with purchaser consolidation, tariff shocks, and price referencing, raising the risk of exits, inventory write-downs, and persistent shortages. Global Competition & Offshoring: How aggressive reference pricing can accelerate shifts in trials, licensing, and high-value manufacturing to countries that offer more predictable returns, and what that implies for long-run U.S. competitiveness. Alternatives To MFN: Ideas from our guests on value-based approaches, targeted incentives, and other tools that can improve affordability without hollowing out domestic capacity, innovation, and resilience in the generic and biosimilar supply chain. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

Recent FDA actions are reshaping key aspects of drug and biologic development, including the Commissioner's National Priority Voucher program, the "plausible mechanism" pathway for personalized therapies, and new draft guidance aimed at streamlining biosimilars and interchangeables. Join Washington, D.C. partner Nathan Beaton and counsel Monica Groat and Chad Jennings as they discuss how these moves differ from traditional policy-making, as well as the practical implications for pricing, manufacturing, M&A, and litigation risk in the healthcare and life sciences industry.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In the ever-dynamic landscape of these industries, recent advancements have underscored both the scientific ingenuity and strategic foresight shaping patient care today.Pfizer has unveiled promising clinical trial data for Tukysa, indicating its potential as a first-line maintenance therapy in HER2-positive breast cancer. This development suggests that Tukysa could delay disease progression, offering patients extended survival prospects and an improved quality of life. Additionally, Pfizer's recent licensing agreement with Yaopharma for YP05002—a small molecule GLP-1 agonist currently in Phase 1 trials aimed at obesity treatment—highlights their strategic push into the rapidly evolving obesity treatment market.Meanwhile, Fondazione Telethon, an Italian nonprofit organization, has achieved a significant milestone with FDA approval for Waskyra—the first gene therapy for Wiskott-Aldrich syndrome. This ex vivo gene therapy directly targets the genetic roots of this rare disease, shifting treatment from symptomatic management to addressing underlying causes. This approval is transformative not only for patients suffering from this condition but also for the broader field of gene therapies, heralding a new era in treating rare genetic disorders.On the strategic front, Eli Lilly's decision to establish a $6 billion active pharmaceutical ingredient manufacturing facility in Huntsville, Alabama, marks a pivotal investment in U.S. manufacturing capabilities. This site will be critical in producing APIs for small molecule and peptide medicines, a testament to Lilly's commitment to meeting growing therapeutic demands while bolstering domestic production resilience—a trend gaining momentum across the industry. In oncology, Eli Lilly's Jaypirca demonstrated an impressive reduction in disease progression during Phase 3 trials for chronic lymphocytic leukemia.Biocon's acquisition of Viatris' stake in their biosimilar subsidiary exemplifies the shifting dynamics within the biosimilars market. This move allows Biocon to consolidate its market position as biosimilars gain traction as cost-effective alternatives to branded biologics. Such strategic realignments are indicative of competitive maneuvering aimed at capturing greater market share and driving down healthcare costs.Roche has made strides with compelling results from its Phase 3 trial of giredestrant, an oral selective estrogen receptor degrader showing a 30% reduction in risk for invasive breast cancer recurrence or death. The significance of this development lies in offering an oral alternative to injectable treatments, potentially improving patient adherence and reshaping standard care protocols for hormone receptor-positive breast cancer. Furthermore, Roche has achieved another regulatory milestone with its monoclonal antibody Gazyvaro gaining EU approval for treating lupus nephritis following successful Phase 3 trials.Innovation continues unabated as Formation Bio forms a new subsidiary through a $605 million deal with Lynk Pharmaceuticals. By securing rights to a next-generation immunology asset, Formation Bio positions itself at the forefront of immunological research developments. Concurrently, BioNTech and Bristol Myers Squibb have reported positive results from Phase 2 trials of Pumitamig for triple-negative breast cancer—validating bispecific antibodies' efficacy within oncology.Collaborative efforts are also reshaping industry landscapes. Bora and Corealis have partnered to create an end-to-end contract development and manufacturing organization for oral solid dose drug development. This collaboration aims to streamline processes and provide scalable solutions through a single contracting source, reflecting a shift towards integrated service models that enhance efficiencySupport the show

To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, click here. To read more about G's discussion with Sarah Yim, MD, from the FDA from the recent 2025 GRx+Biosims conference, click here. To read more on Yim's perspectives on biosimilar policy harmonization, click here.

Drs. Camacho and Lewiecki discuss emerging osteoporosis therapies that are revolutionizing bone health treatment, with promising developments like oral parathyroid hormone medications and dual-action anabolic agents that challenge traditional injection-based approaches. Biosimilars, particularly for denosumab, are expanding patient access by offering highly similar, potentially more affordable alternatives to brand-name drugs, signaling a transformative era in osteoporosis care.

If you're wondering which therapies may influence care delivery, budgets, and decision making in 2026, the pipeline offers an early preview and it points to a year defined by innovation. We're seeing new first in class treatments, thoughtful next generation agents, and a biosimilar market where fewer launches are offset by important competitive shifts driven by recent approvals. John Schoen and Heather Pace from the Center for Pharmacy Practice Excellence join Stacy Lauderdale, Associate Vice President of Evidence-Based Medicine and Drug Information and your Verified RX program host to highlight pipeline agents worth watching and discuss what they may mean for care delivery and spend management in the year ahead.   Guest speakers:  John Schoen, PharmD, BCPS   Senior Clinical Manager of Drug Information    Vizient Center for Pharmacy Practice Excellence    Heather Pace, PharmD Senior Clinical Manager of Drug Information    Vizient Center for Pharmacy Practice Excellence      Host:   Stacy Lauderdale, PharmD, BCPS   Associate Vice President  Vizient Center for Pharmacy Practice Excellence   Show Notes: 01:01 — Episode Scope The focus is non-CGT therapies; CGT pipeline will be covered in Part 2. 01:50 — Therapeutic Areas With the Most Approvals Oncology leads the pipeline. Others include infectious disease, neurology, rare disease, endocrine, hepatology, dermatology, and rheumatology. 02:37 — Biosimilars in 2026: Momentum or Headwinds? Discussion of potential “biosimilar void”—only 10% of expiring biologic patents have biosimilars in development. Emerging role of PBM private-label biosimilars. 03:51 — FDA Draft Guidance on Interchangeability FDA exploring interchangeable designation for all biosimilars. Potential shift away from clinical efficacy studies in favor of analytical comparisons. Guidance still in draft and open for public comment. 05:34 — John's Top Picks for First-in-Class Agents 06:11 — Orviglance First manganese-based, oral MRI contrast agent. Advantages for patients with kidney impairment. Used for liver imaging. 06:20 — Why Non-Gadolinium Matters Lower risk of nephrogenic systemic fibrosis. 06:46 — Tabelecleucel First allogeneic EBV-specific T-cell therapy. For EBV-positive PTLD post-transplant. Could become new standard of care. 07:42 — Tanruprubart First therapy specifically for severe Guillain-Barré Syndrome (GBS). Shows improved outcomes over IVIG and plasma exchange. 08:20 — Comparing to Standard of Care Review of improved real-world data outcomes. 09:03 — Therapies That May Shift Care Delivery 09:32 — Icotrokinra: First oral IL-23 antagonist for plaque psoriasis. 10:00 — Insulin Icodec First once-weekly basal insulin for type 2 diabetes. Resubmitted after safety concerns in type 1 diabetes. 10:59 — Honorable Mentions Camizestrant SERD for ER+/HER2– metastatic breast cancer. Ensitrelvir (COVID-19) Oral option for pre-exposure prophylaxis. Also being evaluated for treatment. Doravirine + Islatravir (HIV) Introduces new NRTTI class. Cefepime + Zidebactam Active against metallo-β-lactamase–producing organisms. 14:05 — Key Biosimilar Launches Omalizumab (Xolair) First biosimilars in asthma/allergy space. Aflibercept (Eylea) High competition expected pending litigation. Pertuzumab (Perjeta) First biosimilar anticipated in oncology. 15:31 — Biosimilars Approved in 2025, Impacting 2026 Ustekinumab (Stelara): first full year of competition Denosumab (Prolia/Xgeva): 10–15 biosimilars expected Eculizumab (Soliris): notable for rare disease market entry 17:17 — John's Closing Thoughts Strong mix of first-in-class advances and next-gen convenience therapies. 17:36 — Heather's Closing Thoughts 2026 will focus on speed and scale after the 2025 biosimilar wave. Pharmacists pivotal in ensuring smooth patient transitions.   VerifiedRx Listener Feedback Survey: We would love to hear from you - Please click here   Subscribe Today! Apple Podcasts Spotify YouTube RSS Feed

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the intricate tapestry of scientific advancements, regulatory decisions, and strategic maneuvers shaping our industry.One of the notable stories involves Agios Pharmaceuticals, which is pushing forward with its sickle cell disease treatment, Pyrukynd, for FDA approval. This comes despite mixed results from their Phase 3 clinical trials, which led to a significant drop in their stock value. This scenario underscores the complexities of navigating clinical trial outcomes while pursuing breakthroughs in treating challenging diseases like sickle cell.Arrowhead Pharmaceuticals has marked a significant milestone with the FDA's approval of Plozasiran. This achievement not only marks Arrowhead's entry into the commercial sector but also highlights the competitive dynamics within biotech, as companies like Ionis Pharmaceuticals vie for market dominance with innovative therapies. Further strengthening its position, Arrowhead also received FDA approval for Redemplo, a siRNA-based therapeutic for rare genetic metabolic disorders. Despite facing volatility due to safety concerns in its partnership with Sarepta Therapeutics, this approval underscores RNA interference therapies' potential in precision medicine.In corporate strategy news, Alkermes is making moves to acquire Avadel Pharmaceuticals, offering up to $2.37 billion and overshadowing a competing bid from Lundbeck. Such acquisitions are part of a broader trend of consolidation in the industry aimed at expanding portfolios and market reach. Avadel's decision to accept Alkermes' revised offer over Lundbeck's bid highlights ongoing consolidation trends as companies expand their portfolios in competitive markets like narcolepsy drugs.On the investment front, Celltrion has committed $478 million to upgrade a U.S. manufacturing facility acquired from Eli Lilly. This expansion is crucial for increasing manufacturing capabilities within the biosimilars sector, where demand for cost-effective therapeutics is on the rise. Additionally, Celltrion's exploration beyond biosimilars with a potential $350 million deal involving Trioar's antibody platform demonstrates ambition to diversify its portfolio towards innovative biologics.Teva Pharmaceuticals is fostering innovation by inviting startups to tackle key challenges within biopharma through a global platform. This initiative reflects a growing trend toward open innovation and collaboration, seeking novel solutions to complex issues across research and development and manufacturing efficiencies.In regulatory news, the controversial $7.4 billion settlement plan involving the Sackler family and Purdue Pharma has received approval from a bankruptcy judge. This paves the way for Purdue's transformation into Knoa Pharma and highlights ongoing legal and ethical reckonings related to opioid liabilities within the industry.Cytokinetics remains committed to its independent path as it awaits FDA approval for its cardiovascular drug Aficamtem. The company's determination to commercialize without big pharma support reflects a trend where smaller biotech firms strive for autonomy while bringing first-in-class drugs to market.On an infectious disease front, Merck has demonstrated significant progress with its HIV treatment Islatravir in Phase 3 trials. This places Islatravir as a potential competitor against Gilead's Biktarvy, showcasing ongoing innovation within antiviral drug development.Additionally, Dexcom has gained clearance for its type 2 diabetes software integrating continuous glucose monitoring technology. This advancement exemplifies how digital health technologies are transforming chronic disease management bySupport the show

Send us a textGood morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a myriad of pivotal changes and advancements that have been shaping our industry.The competitive nature of acquisitions within the biopharma sector has been exemplified by recent strategic buyouts. Lundbeck's decision to outbid Alkermes for Avadel Pharmaceuticals highlights how companies are leveraging acquisitions to expand their capabilities and portfolios. Similarly, Pfizer's finalized acquisition of Metsera after a fierce bidding war with Novo Nordisk underscores the importance of securing valuable assets to strengthen positioning in critical therapeutic areas, such as obesity treatment, where demand continues to rise.Regulatory milestones remain at the heart of industry progress. Organon and Henlius's Poherdy recently received FDA approval as a biosimilar to Roche's Perjeta, offering a new treatment avenue for HER2-positive breast cancer patients. This approval is noteworthy as biosimilars play an essential role in oncology by providing similar efficacy to original biologics but at reduced costs, thereby enhancing healthcare affordability and accessibility. In Europe, the EMA's Committee for Medicinal Products for Human Use has endorsed several innovative drugs, including Otsuka's Dawnzera for hereditary angioedema and Lilly's Inluriyo for certain cancer types. These endorsements reflect the growing pipeline of treatments addressing both rare genetic disorders and widespread diseases.Merck & Co.'s acquisition of Cidara Therapeutics for $9.2 billion underscores a strategic pivot towards bolstering its antiviral portfolio. This deal is particularly significant given Cidara's promising influenza antiviral candidate, initially abandoned by Johnson & Johnson. In an era where infectious diseases pose ever-evolving challenges, Merck's investment in antivirals reflects a commitment to advancing therapeutic solutions in this crucial area.However, drug development's inherent uncertainties were highlighted by Bristol Myers Squibb and Johnson & Johnson's joint anticoagulant venture, which faced termination due to a Phase 3 trial failure. This setback emphasizes the challenges and risks entailed in developing novel therapeutics, particularly within high-stakes areas like cardiovascular health.Leadership changes can significantly impact corporate strategy, as seen with Bavarian Nordic following an unsuccessful private equity takeover attempt. Such shifts can influence investor confidence and reshape strategic directions.Investment trends also paint an optimistic picture for innovation within the sector. European life sciences investor Medicxi's successful raising of €500 million signifies robust financial support for biotech ventures. This influx of capital is vital for propelling early-stage research and development efforts across Europe, fostering breakthroughs in chronic and rare disease treatments.In terms of scientific innovation, advancements in bispecific antibody production through AI/ML-driven molecular design promise higher yields and enhanced quality. These technological innovations could revolutionize complex biologics manufacturing, potentially accelerating timelines and expanding therapeutic possibilities.The regulatory landscape is seeing significant activity as well. Notably, FDA officials introduced a novel pathway aimed at accelerating gene editing therapies' development and approval. By facilitating faster market entry for personalized medicines, this regulatory innovation could pave the way for treatments tailored to individual genetic profiles.Kyowa Kirin's collaboration with Kura Oncology reached a milestone with FDA approval for an oral medication targeting acute myeloidSupport the show

Do you know what words patients do not want to hear? Credit available for this activity expires: 11/13/2026 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/paving-way-success-integrating-biosimilars-multiple-2025a1000v8w?ecd=bdc_podcast_libsyn_mscpedu

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today's focus is on a series of significant advancements that are poised to reshape the landscape of drug development, regulatory standards, and patient care.Eli Lilly has made remarkable strides with its dual-action obesity medications, Zepbound and Mounjaro. Despite being removed from the CVS formulary, these drugs have achieved exceptional sales figures, reaching $10 billion in a single quarter. This success can be attributed to Lilly's innovative direct-to-consumer sales strategy, which exemplifies how modern marketing approaches can overcome traditional market barriers. Additionally, Eli Lilly's partnership with Walmart to expand access to Zepbound through retail pharmacy pickups exemplifies a strategic approach to enhancing patient access to crucial medications. By leveraging Walmart's extensive retail network, this collaboration facilitates easier access to obesity treatments—a significant public health challenge—enhancing both patient convenience and broadening market reach for Lilly's products. These achievements not only highlight the potential of strategic marketing but also underscore a growing demand for effective obesity treatments within the pharmaceutical industry.In another exciting development, Alnylam Pharmaceuticals has reported impressive sales figures for Amvuttra, a treatment for transthyretin amyloid cardiomyopathy. Surpassing analysts' expectations, this success signals a growing market for treatments targeting rare diseases and emphasizes the importance of strategic market expansion to reach underserved patient populations.Meanwhile, Bristol Myers Squibb's anticipated schizophrenia treatment, Cobenfy, has experienced a lukewarm market entry. While meeting initial expectations in its first year, it has yet to create the breakthrough impact investors anticipated. This situation highlights the challenges even well-hyped pharmaceuticals face upon launch and underscores the need for continuous strategic planning to ensure market penetration and sustained growth.A surprising development in mergers and acquisitions comes from Novo Nordisk's $6.5 billion counteroffer to acquire Metsera, an obesity biotech initially targeted by Pfizer. This aggressive move reflects intense competition in the obesity drug market and illustrates the high stakes involved in acquiring promising biotech assets that could potentially transform treatment paradigms for chronic conditions like obesity.The vaccine industry is navigating its own set of challenges with declining sales across the board. However, Merck's adult pneumococcal vaccine Capvaxive has shown promising initial sales figures. As the first pneumococcal vaccine specifically designed for adults, Capvaxive indicates a potential niche market that Merck could successfully capture.On the regulatory front, significant measures are being taken by the FDA to boost biosimilar availability against drug pricing pressures. New draft guidance aims to eliminate clinical testing requirements for biosimilars and categorize all approved biosimilars as "interchangeable." This initiative could significantly reduce biologic medicine costs post-patent expiration and increase competition in the market, potentially making essential medications more accessible to patients. Additionally, the FDA is proposing streamlined biosimilar approval pathways aimed at reducing overall bio-drug costs—a welcome move reflecting concerted efforts to make essential medications more affordable and accessible globally.Argenx has reported positive trial results for Vyvgart in treating generalized myasthenia gravis (gMG), highlighting its commitment to addressing unmet needs within this patient population. These findings could expand treatment options for gMG patients who have been previously overlooked in thSupport the show

This week in review covers 5 episodes from October 20 to October 24, featuring major developments in pharmaceutical and biotech industries including strategic acquisitions, regulatory updates, and clinical trial results.Episodes included:1. Pharma Innovations: AI's Impact and Strategic Shifts2. Strategic Acquisitions and AI Revolutionize Pharma Landscape3. Industry Shifts: Novo Nordisk's Revamp & ADC Breakthroughs4. Transformative Advances in Precision Oncology and ADCs5. Transformative Oncology Breakthroughs and Regulatory ShiftsKey topics covered:- Strategic acquisitions and partnerships- Regulatory updates and FDA approvals- Clinical trial results and breakthroughs- Industry trends and market developmentsStay informed with Pharma Daily's comprehensive coverage of the pharmaceutical and biotech world.Support the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of pivotal changes and innovations shaping the industry landscape.Let's begin with a significant acquisition that is resonating across the sector. Alkermes has strategically acquired Avadel Pharmaceuticals for a noteworthy $2.1 billion. This acquisition is primarily aimed at Avadel's long-acting narcolepsy drug, Lumryz. This move not only acts as a growth catalyst for Alkermes but also strategically positions the company to potentially advance its own narcolepsy candidate, Alixorexton. This acquisition highlights a broader trend within the industry: a shift towards consolidation and specialization in niche therapeutic areas, reflecting the ongoing strategic maneuvering within the pharmaceutical sector to enhance therapeutic portfolios.In regulatory developments, there is an ongoing discussion around FDA cancer drug policies that's gaining attention. Eli Lilly's Oncology President has highlighted the need for clearer regulatory pathways. The debate revolves around whether to prioritize survival metrics without crossover incentives or encourage U.S. participation through crossover designs. This underscores a tension between maintaining regulatory rigor and offering flexibility in clinical trial design—a balance that impacts how quickly new oncology therapies can reach patients.Turning to international trade, there are significant movements as the Trump administration initiates a probe under Section 301 of the Trade Act of 1974. The aim is to assess if foreign nations are contributing their fair share to drug costs. Such an investigation could lead to tariffs, potentially altering global pharmaceutical trade dynamics and influencing international pricing strategies. Reports suggest that former President Donald Trump is exploring strategies to impose tariffs on U.S. trading partners not adequately compensating for pharmaceuticals, reflecting ongoing tensions regarding international drug pricing.Technology is revolutionizing life sciences commercialization strategies, with AI playing a pivotal role. Despite many organizations not being fully prepared for this digital shift, companies like Real Chemistry are pioneering AI applications to navigate regulatory complexities such as FDA marketing compliance. This digital transformation is set to redefine how pharmaceutical companies engage with patients and healthcare providers, enhancing efficiency and compliance.In legal news, Regeneron has settled a patent dispute with Celltrion over Eylea, allowing for the launch of a biosimilar by the end of 2026. This settlement is part of the growing biosimilars market, which offers cost-effective alternatives to high-priced biologics and enhances patient access to essential therapies.The industry's focus on oncology is further exemplified by Takeda's $1.2 billion upfront payment to Innovent Biologics for cancer assets. This deal includes substantial milestone payments, marking oncology as a key growth area post-Entyvio era and highlighting the high stakes associated with breakthrough cancer therapies. Continuing with significant industry maneuvers, Takeda Pharmaceuticals has announced a potential investment up to $11.4 billion to acquire three antibody-drug conjugates from Innovent Biologics. This deal includes an upfront payment of $1.2 billion and up to $10.2 billion in milestone payments—highlighting Takeda's commitment to expanding its oncology portfolio with innovative therapies that promise enhanced treatment outcomes for cancer patients.Ipsen's acquisition of ImCheck Therapeutics for $1.6 billion further emphasizes this focus on novel cancer treatments. The move includes ImCheck's mid-stage leukemia monoclonal antibody ICT01—an asset aimed at acute myeloid leukemia—indicating Ipsen's strategic push intSupport the show

Join us as we celebrate 10 years of biosimilars. In this episode of The Counter Talk™ Podcast host Jason Callori speaks with Dracey Poore, Director of Biosimilars at Cardinal Health to discuss the evolution of biosimilars and their impact on the healthcare landscape. Dracey shares valuable information on its importance within the market and role of pharmacists. Click here to download the report and learn more.          Links:  Apple Music – https://podcasts.apple.com/us/podcast/10-years-of-biosimilars-a-decade-of-progess/id1616706265?i=1000712269701  Spotify – https://open.spotify.com/episode/16rgiAVRqq2gqQBrXk1nDp  Cardinal Health - https://www.cardinalhealth.com/en/services/retail-pharmacy/resources-for-pharmaceutical-distribution/independent-pharmacy-podcast  

In this episode, the team from The Ohio State University Wexner Medical Center discusses their award-winning ASHP Best Practices submission.  They share how the program leveraged the unique expertise of pharmacist informaticists to take advantage of  EHR and build tools to automate the selection of preferred biosimilar, iron and Biosimilars, Iron, and 505(b)(2)  products based on the patient's insurance and hospital formulary preferences and time to payor approval for patients, reduced the administrative burden of the PA process, and improved the quality of our patient care. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

In this episode of the Vital Health Podcast, host Duane Schulthess speaks with John Murphy, President and CEO of the Association for Accessible Medicines (AAM), to discuss how U.S. purchasing dynamics and thin margins drive shortages, the evolving biosimilar landscape amid insurer vertical integration, the Inflation Reduction Act (IRA)’s ripple effects on plan risk and rebates, Most Favored Nation (MFN) policy proposals, and what it will take to reshore capacity while preserving competition and patient access. Key Topics: Generic Pricing Pressures: Purchaser consolidation, sterile injectables, margin squeeze, and exits. Drug Shortage Economics: Quality investments, underpriced redundancy, lessons from saline disruptions. Biosimilar Market Dynamics: Private-label payer programs, rebate tactics, chilling pipeline investment. Inflation Reduction Act (IRA) and Coverage: Part D risk shift to plans, negotiation uncertainty, and Medicare access delays. Tariffs and Reshoring: API onshoring realities, carve-outs to avoid shortages, resilient capacity building. Opinions expressed are those of the speakers.See omnystudio.com/listener for privacy information.

Listen in as we discuss considerations, challenges, and strategies related to the use and switching of biosimilars in clinical practice.  You'll hear communication tips to address patient and prescriber concerns as well as operational considerations for integrating biosimilars into practice.  Special guests:Bharati Bhardwaja, PharmD, BCPS, LSSBBRheumatology Clinical Pharmacy SpecialistKaiser Permanente ColoradoMegan May, PharmD, BCOP, FHOPA, FAPOClinical Oncology Pharmacy SpecialistBaptist Health Lexington/Hamburg Cancer Care CenterYou'll also hear practical advice from TRC's Editorial Advisory Board member:Craig D. Williams, PharmD, FNLA, BCPSClinical Professor of Pharmacy PracticeOregon Health and Science UniversityFor the purposes of disclosure, Dr. Megan May reports relevant financial relationships [lung cancer] with Amgen, AstraZeneca, Pharmacosmos (speakers bureau). The other speakers have nothing to disclose.  All relevant financial relationships have been mitigated.This podcast is an excerpt from one of TRC's monthly live CE webinars, the full webinar originally aired in August 2025.TRC Healthcare offers CE credit for this podcast. Log in to your Pharmacist's Letter, Pharmacy Technician's Letter,or Prescriber Insights account and look for the title of this podcast in the list of available CE courses.Claim CreditThe clinical resources mentioned during the podcast are part of a subscription to Pharmacist's Letter, Pharmacy Technician's Letter, and Prescriber Insights: FAQ: Facts About BiosimilarsChart: Comparison of Insulins (United States)Chart: Biologics for Rheumatoid ArthritisChart: Biologics for Crohn's DiseaseUse code mt1025 at checkout for 10% off a new subscription.Send us a text****

Episode 83 of the Astonishing Healthcare podcast features returning guest, Bridget Mulvenna (VP, National Business Development at Capital Rx)! We discuss specialty drugs, pharmaceutical manufacturer rebates, and the shift to biosimilars. Yes, GLP-1s come up as well (how could they not?), and Bridget explains how employer plan sponsors can consider opportunities to provide access to these medications while not ignoring their inflationary potential and the economic impact on the plan - i.e., how to pivot from a rebate-driven models to a net-cost approach, facilitating more accurate cost management and budgeting.HighlightsTraditional PBMs remain focused on rebate value, which doesn't always mean the lowest net cost for the plan sponsor.Biosimilar adoption and precision formularies/benefits are a threat to old models.Plan sponsors must get [and use] their data - without detailed information, it's impossible to determine the true net cost or implement effective communication and education strategies.GLP-1s should be supported by wellness programs, and respecting FDA labeling is crucial.Surprisingly, many plan sponsors still choose the PBM that offers the highest rebates.Related ContentWill Biosimilar Rebates Pass-Through?Health Benefits 101: The Importance of a Transparent PBM ModelHow to Manage Pharmacy Benefit Spend in a GLP-1 WorldPharmacy Benefits 101: What is a Formulary?Pharmacy Benefits 101: Pharmaceutical RebatesFor more on the importance of access to plan data:

This special vodcast series provided by The Center for Biosimilars® was developed in partnership with the AAM and Biosimilars Council. Check out part 1 of the series featuring a discussion between Giuseppe Randazzo and Craig Burton, former executive director of the Biosimilars Council and current senior vice president of government affairs and policy at Fresenius Kabi. References Jeremias S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. February 5, 2025. Accessed May 3, 2025. https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars

Join us as we celebrate 10 years of biosimilars. In this episode of The Counter Talk™ Podcast host Jason Callori speaks with Dracey Poore, Director of Biosimilars at Cardinal Halth to discuss the evolution of biosimilars and their impact on the healthcare landscape. Dracey shares valuable information on it's importance within the market and role of pharmacists. Click here to download the report and learn more. https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/biosimilars-report.html

Biosimilars, a group of drugs that are similar to biologic drugs, which are medications produced using living organisms and are often used to treat complex medical conditions. Biosimilars were first introduced to the prescription drug market about a decade ago and as of March, the FDA had approved scores of products that may be used interchangeably for some of the most expensive brand-name biologic pharmaceuticals, treating conditions such as diabetes and cancer. While biologics make up only about 2% of prescriptions, they account for as much as 46% of total drug spending in the U.S.The three guests on this podcast all have expertise on different aspects of this topic and discuss the use of biosimilar medicines in health care and the possible cost savings when they are used in place of originator biologic medications. Luca Maini is an economist who studies the pharmaceutical industry and is an assistant professor at Harvard Medical School. Chad Pettit is executive director of global government affairs for Amgen, a biotechnology company. Erin Glossop is a policy specialist at NCSL who follows state policies around pharmaceuticals.Maini discussed his research into how the introduction of biosimilars into a market affects the price of brand-name biologics. Pettit explained the perspective from the biotechnology industry and how he thinks the industry will develop in the next several years. Glossop explained how some states are developing bipartisan policy around biosimilar access and efforts to find cost-savings these products might offer. ResourcesAmgen BiosimilarsAssessing the Biosimilar Void in the U.S., IQVIABiosimilars in the United States 2023-2027, IQVIABiosimilar Uptake In The US: Patient And Prescriber Factors, Dongzhe Hong, et al.Coverage for Biosimilars vs Reference Products Among US Commercial Health Plans, James D. Chambers, et al.Exploring the Influence of Health Insurance Plans on Biosimilar Adoption Rates, Mariana Socal, et al.Factors Associated with Biosimilar Exclusions and Step Therapy Restrictions Among US Commercial Health Plans, Tianzhou Yu, et al.Luca Maini website

Is your osteoporosis treatment plan up to date? With new developments on the horizon, it's more important than ever to know how the latest research and strategies can help protect your bones. I just returned from the Interdisciplinary Symposium on Osteoporosis, and I'm excited to share the latest updates on osteoporosis diagnosis and treatment for 2025. My husband, Dr. Craig Bissinger, joins me in discussing bone density testing, medication updates, and the evolving role of exercise programs in osteoporosis prevention.  Discover how safe strength training and weight-bearing exercises show remarkable results in improving bone density. As we understand more about the disease, it's clear that exercise plays a significant role in bone health, and it's more important than ever to tailor treatments to each individual's needs. Tune in to learn how these advancements can help you take control of your bone health!   “It shouldn't be that everyone's in their own silos, but when everybody's working together and root causes are addressed, things get better." ~ Margie Bissinger   In this episode: - [00:48] - The growing importance of exercise in osteoporosis management - [01:15] - Introduction to the Bone Fit program for therapists - [03:33] - Strength training and weightlifting for bone density - [09:42] - Gut microbiome and bone health connection - [10:22] - Medication updates for osteoporosis in 2025 - [18:04] - The role of radius bone mineral density (BMD) - [21:09] - Trabecular Bone Score (TBS) and why it's important - [24:09] - Biosimilars and other medications for bone health - [25:17] - When to get a DEXA scan - [27:08] - Protein requirement for older adults  - [28:20] - Nonunion and what it indicates about your health   Resources mentioned - Find a BoneFit practitioner - https://tinyurl.com/ptbonefit - Get quality supplements at a discount from Fullscript - http://tinyurl.com/supplementsforless   More about Margie - Website - https://margiebissinger.com/  - Facebook - https://www.facebook.com/p/Margie-Bissinger-MS-PT-CHC-100063542905332/  - Instagram - https://www.instagram.com/margiebissinger/?hl=en    DISCLAIMER – The information presented on this podcast should not be construed as medical advice. It is not intended to replace consultation with your physician or healthcare provider. The ideas shared on this podcast are the expressed opinions of the guests and do not always reflect those of Margie Bissinger and Happy Bones, Happy Life Podcast.   *In compliance with the FTC guidelines, please assume the following about links on this site: Some of the links going to products are affiliate links of which I receive a small commission from sales of certain items, but the price is the same for you (sometimes, I even get to share a unique discount with you). If I post an affiliate link to a product, it is something that I personally use, support, and would recommend. I personally vet each and every product. My first priority is providing valuable information and resources to help you create positive changes in your health and bring more happiness into your life. I will only ever link to products or resources (affiliate or otherwise) that fit within this purpose.