Podcasts about biosimilars

To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, click here.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 Emerging role of PBM private-label biosimilars. 03:51 — FDA Draft Guidance on Interchangeability FDA exploring interchangeable designation for all biosimilars.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****

Was den synthetischen Medikamenten das Generikum, ist den biologischen das Biosimilar: Ein Nachahmerprodukt, das gleich wirksam ist wie das Original, aber günstiger. Gemeinsam mit Prof. Markus Jörger von HOCH schauen wir uns an, wie Biosimilars entwickelt und zugelassen werden und welchen Einfluss sie auf die Kosten im Gesundheitssystem haben. Unterstützt von IntergenerikaDiese Folge wurde ermöglicht durch die Unterstützung von Intergenerika, dem Verband der Generika und Biosimilars Anbieter in der Schweiz. Biosimilars ermöglichen den Patienten und Patientinnen einen sicheren Zugang zu hoch innovativen Therapien und leisten einen wesentlichen Beitrag zur Kostendämpfung im Schweizer Gesundheitswesen. Wir freuen uns sehr über Rückmeldungen, Ideen und Themenvorschläge für unseren Podcast. Schreib uns gerne auf Instagram (@lebenmitkrebs_ch), Facebook (@LebenmitKrebsSchweiz) oder via E-Mail auf info@lebenmitkrebs.ch. Alles Liebe Nadine & Sandra Disclaimer:Gekennzeichnete Folgen wurden mit finanzieller Unterstützung der jeweiligen Unternehmen erstellt. Die Unternehmen haben keinen Einfluss auf den finalen Inhalt der Folgen. Die Unternehmen sowie die Produzentin übernehmen keine Verantwortung für wiedergegebenen Meinungen und Aussagen von Interviewpartnern in den jeweiligen Folgen. Die unterstützenden Unternehmen und die Redaktion geben ebenso wenig individuelle Empfehlungen in Bezug auf die Diagnose oder den Behandlungsplan von Patienten und Patientinnen. Diese Fragen sind mit den behandelnden Ärzt*innen zu besprechen.

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:

Wie findet man eigentlich neue Krebstherapien? Und wie werden die Medikamente dafür entwickelt? Diesen Fragen gehen wir in dieser Staffel auf den Grund. Wir verfolgen den Weg von der ersten Idee im Labor bis zur Entwicklung eines Wirkstoffs und seiner Anwendung bei Patientinnen und Patienten. Und wir gehen noch einen Schritt weiter: Wir schauen uns an, wie aus einem Originalpräparat später Generika oder Biosimilars entstehen. 

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

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. DOWNLOAD

Generics Bulletin editors Dave Wallace and Dean Rudge discuss the Global Generics & Biosimilars Awards 2025, providing all the key details of the event coming up in Frankfurt this October, along with tips on how to make the most of your entries and opportunities to get more involved with the event.

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.

REFERENCE 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

Guest: Andre Harvin, PharmD, MS, MBA Biosimilars have greatly impacted the US healthcare system over the last decade, creating cost savings and increasing access for patients.1,2 However, although some biosimilars have seen significant adoption, not all biosimilars have been able to achieve sustainable market use.1 Learn about the barriers to biosimilar adoption in the US and strategies for overcoming them from Dr. Andre Harvin. Dr. Harvin is the chief pharmacy officer at Cone Health in Greensboro, North Carolina. References: AAM, The U.S. Generic & Biosimilar Medicines Savings Report, September 2023 IQVIA Institute for Human Data Science, Biosimilars in the United States 2023-2027: Competition, Savings, and Sustainability, January 2023 © Fresenius Kabi USA, LLC 2025 03/2025

Drs. Akshay Thomas and Priya Vakharia join to preview the April 2025 edition of Retinal Physician, focusing on current and future therapies for neovascular AMD.Relevant Financial Disclosures: Dr. Sridhar has consulted for Genentech, Regeneron, and Eyepoint. Dr. Vakharia has consulted for Regeneron, Ocular Therapeutix, and Eyepoint.You can claim CME credits for prior episodes via the AAO website. Visit https://www.aao.org/browse-multimedia?filter=Audi

Biosimilars have been around for nearly a decade, but with Humira's list price of around $7,000, biosimilars for the drug are making an incredible splash in the pharmacy industry. With several biosimilars already launched in 2025 and more in the pipeline, many plan sponsors are wondering how to navigate the integration of these products into their pharmacy benefit strategies.   In this episode, Employers Health's Mike Stull chats with Jeff Casberg, head of clinical pharmacy at IPD Analytics to discuss all things biosimilars, including how biosimilar launch dates and pricing are determined, cost savings associated with these products, the importance of biosimilar formulary positioning and more.    Want to hear more from Jeff? Join us at the Annual Benefits Forum April 22-23 in Columbus, Ohio, where he'll present "The Impact of New Drugs and Therapies on PBM Spend." 

First Xolair biosimilar approved, Wearable furosemide loop diuretic gains expanded indication; Implant approved for macular telangiectasia; Novel treatment shows promise in hypertension; And testing reveals high benzene levels in over-the-counter acne treatments.

Der Basler Generika-Konzern Sandoz verzeichnet im ersten Jahr seit der Abspaltung von Novartis grosses Wachstum bei Umsatz und Gewinn. Ein wichtiger Treiber sind sogenannte Biosimilars. Konzernchef Richard Saynor beabsichtigt, im wichtigen Absatzmarkt USA Marktführer zu werden. SMI: +0.8%

With biosimilars entering the market for the treatment of osteoporosis, there is a lot healthcare providers need to know. On this episode, Dr. Alan Low, a Clinical Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia, Care Director at MedInfuse Health, Primary Care Pharmacist / Pharmacy Lead at BioPro Biologics Pharmacy Clinical and a member of Osteoporosis Canada's Scientific Advisory Council, discusses how biologics and biosimilars work, the benefits of biosimilars and how to speak to patients about these new treatment options.

Show notes 1. Jeremias S. A banner year for biosimilars: The 19 FDA approvals from 2024. The Center for Biosimilars. January 21, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/a-banner-year-for-biosimilars-the-18-fda-approvals-from-2024 2. Jeremias S. FDA approves Celltrion's Avtozma as third tocilizumab biosimilar. The Center for Biosimilars. January 31, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/fda-approves-celltrion-s-avtozma-as-third-tocilizumab-biosimilar 3. Jeremias S. Senators introduce bipartisan legislation to protect skinny labeling. The Center for Biosimilars. January 2, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/senators-introduce-bipartisan-legislation-to-protect-skinny-labeling 4. Jeremias S. FTC releases second report on PBMs meddling in generic drug markets. The Center for Biosimilars. January 19, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/ftc-releases-second-report-on-pbms-meddling-in-generic-drug-markets 5. Santoro C. Earlier patent litigation could accelerate US biosimilar market entry. The Center for Biosimilars. January 9, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/earlier-patent-litigation-could-accelerate-us-biosimilar-market-entry 6. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us 7. Jeremias S, Chambers JD. The banking of biosimilars: insights from a leading health economist. The Center for Biosimilars. February 4, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/the-banking-of-biosimilars-insights-from-a-leading-health-economist 8. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars. February 5, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars 9. Jeremias S. Biosimilars drive cost savings and achieve 53% market share across treatment areas. The Center for Biosimilars. January 16, 2025. Accessed February 7, 2025. https://www.centerforbiosimilars.com/view/biosimilars-drive-cost-savings-and-achieve-53-market-share-across-treatment-areas

Elizabeth Hughes, DNP, AGPCNP-BC, Sharon Tymkiw, MSN, MBA, RN, and Karen M. Vuckovic, PhD, APRN, ACNS-BC join the podcast to explore biosimilars in patient treatment. Be sure to check out their article in our December 2024 issue, “Biosimilars vs. originators: A comprehensive guide for nurses on efficacy, safety, and patient care.”

In this episode of Molecule to Market, you'll go inside the outsourcing space of the global drug development sector with Raman Sehgal, Founder & Global President at ramarketing & Host of Molecule to Market. For this milestone episode, your host is Molecule to Market's first guest from back in 2020, JoyL Silva, Customer Engagement Lead for the US Primary Care portfolio at Pfizer, who discusses the pharmaceutical and biotechnology supply chain with Raman Sehgal covering: Raman reflects on the podcast's evolution, from its inception during COVID-19 to becoming a globally recognized platform They discuss key trends in the pharma outsourcing sector and the impact of guests who have contributed to the podcast's success Raman shares highlights from his career, including the growth of his companies, ramarketing and Lead Candidate, and his private equity ventures Insights into balancing work and family life, with advice on being present and managing priorities A desert island question where Raman chooses which podcast guests he'd bring along, plus behind-the-scenes stories of challenges and humorous incidents JoyL Silva is the Customer Engagement Lead for Pfizer's US Primary Care portfolio, overseeing sales and account management across therapeutic areas such as Migraine, Cardiovascular, Anti-virals, and Vaccines. She leads high-performing teams that drive a $20B portfolio through agile methodologies and talent development. With over 20 years at Pfizer, JoyL has excelled in commercial leadership, business transformations, and operational expertise, delivering impactful results across multiple roles, including VP for Hematology and Biosimilars, General Manager of Pfizer CentreOne, and US/Global Commercial Lead for PAXLOVID, where she spearheaded global strategies and partnerships for Pfizer's COVID-19 antiviral therapeutic. JoyL frequently speaks at industry forums and contributes her expertise to various publications and professional boards, including the Pharma & Biopharma Outsourcing Association. Her accolades include being named to the Medicine Maker Power List and PharmaVOICE 100 Most Inspiring People in the Life Sciences Industry, as well as receiving awards such as the Scrip Best Partnership Alliance Award and Putnam Media Top 20 Influential Women in Manufacturing. Her career reflects a strong commitment to driving innovation and fostering leadership in the life sciences sector. Please subscribe, tell your industry colleagues and join us in celebrating and promoting the value and importance of the global life science outsourcing space. We'd also appreciate a positive rating!    Molecule to Market is also sponsored and funded by ramarketing, an international marketing, design, digital and content agency helping companies differentiate, get noticed and grow in life sciences.

Here are the top 5 episodes of Not So Different from 2024. Number 5: Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved Number 4: Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars Number 3: Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health's 2024 Biosimilar Report Number 2: Biosimilars in America: Overcoming Barriers and Maximizing Impact Number 1: Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024

Show Notes   1. Jeremias S. Skyrizi overtakes Humira: “product hopping” leaves biosimilar market in limbo. The Center for Biosimilars. November 7, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/skyrizi-overtakes-humira-product-hopping-leaves-biosimilar-market-in-limbo 2. Jeremias S. Celltrion sets sights on 2030 with expanded biosimilar portfolio, market reach. The Center for Biosimilars. November 6, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/celltrion-sets-sights-on-2030-with-expanded-biosimilar-portfolio-market-reach 3. Ferreri D. Making the cost of IBD care sustainable. The Center for Biosimilars. November 2, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/making-the-cost-of-ibd-care-sustainable 4. Ferreri D. Achieving PFS in advanced gastric cancer with HLX02 biosimilar, chemotherapy. The Center for Biosimilars. November 23, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/achieving-pfs-in-advanced-gastric-cancer-with-hlx02-biosimilar-chemotherapy 5. Ferreri D. Subcutaneous infliximab CT-P13 superior to placebo as maintenance therapy for IBD. The Center for Biosimilars. November 16, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/subcutaneous-infliximab-ct-p13-superior-to-placebo-as-maintenance-therapy-for-ibd 6. Ferreri D. Challenges, obstacles, and future directions for anti-TNF biosimilars in IBD. The Center for Biosimilars.November 9, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/challenges-obstacles-and-future-directions-for-anti-tnf-biosimilars-in-ibd 7. Jeremias S. Breaking down biosimilar barriers: the patent system.The Center for Biosimilars. November 11, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system 8. Jeremias S. Breaking down biosimilar barriers: payer and PBM policies. The Center for Biosimilars. November 13, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-payer-and-pbm-policies 9. Poore D. Breaking down biosimilar barriers: interchangeability. The Center for Biosimilars. November 14, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-interchangeability 10. The Center for Biosimilars Staff. Webinar: streamlining the regulatory process to advance access to biosimilars. The Center for Biosimilars. November 21, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/webinar-streamlining-the-regulatory-process-to-advance-access-to-biosimilars 11. Jeremias S. Can global policies to boost biosimilar adoption work in the US? The Center for Biosimilars. November 17, 2024. Accessed November 27, 2024. https://www.centerforbiosimilars.com/view/can-global-policies-to-boost-biosimilar-adoption-work-in-the-us-

Reducing the cost of prescription drugs has been a bipartisan priority for years. One recent effort is the Preserve Access to Affordadble Generics and Biosimilars Act (S. 142), sponsored by Sen. Klobuchar with the support of Sen. Grassley and others. This bill would give the FTC new authority to investigate settlements between branded and generic drug companies that delay generic/biosimilar market entry and are deemed anticompetitive. The bill proposes allowing the FTC to make factual findings and liability determinations that the district court applies when computing damages. Our expert panel will discuss whether this bifurcated administrative/judicial arrangement can be squared with SEC v. Jarkesy and more broadly discuss issues around patent settlements in the bio/pharma space. Featuring:Matthew S. Hellman, Partner, Jenner & BlockWilliam M. Jay, Partner, Appellate & Supreme Court Litigation, Goodwin Procter LLPProf. Emily Michiko Morris, David L. Brennan Endowed Chair, Associate Professor, and Associate Director of the Center for Intellectual Property Law & Technology, The University of Akron School of LawMatthew D. Rowen, Partner, Clement & Murphy PLLCModerator: Brian Pandya, Partner, Duane Morris LLP--To register, click the link above.

A New ACR Cancer Survival in RA "Changing Mindsets about Methotrexate Side Effects" Control RA, Build Stronger Bones Cumulative Steroid Use and Cardiovascular Events Disease Activity in RA-ILD Do TNFis and JAKis Prevent Cancer!? Estimating Inflammation, Damage and Patient Distress Finding the Right Combination Therapy in RA Implantable Vagus Nerve Stimulator for RA Is Frequent Lab Monitoring Necessary? Long Term Follow up from APIPPRA Metabolic Dysregulation and RA Interstitial Lung Disease Native Americans with RA Die Young Paraoxonase-1: Possible Biomarker for Progression to RA Pred Softly: Steroids Predicting Flares in Rheumatoid Arthritis RA Roundup: Is LDA Inappropriate? What about Statins for JAKs? RA Treatment Adherence: Is decision making really shared? RA: One JAK to Rule Them All? Sonelokimab in PsA: Phase 2 Data Treat-to-Target Improves Fertility in Women with RA Treatment Considerations for RA-ILD Treatment Strategies in RA Use of AI in Hand Ultrasound Scoring Vaccine Responses:The DMARD Counts What's New in Relapsing Polychondritis? What's The State of Biosimilars?

Our Thanksgiving episode of Mercalis in Motion is now available!  In this episode, Mercalis team members Michael Turner, Terry Cato, and Blake Johnson join us to discuss the impact the introduction of biosimilars has made on the pharmaceutical marketplace and how pharma manufacturers are developing strategy for biosimilar patient support services.

Best Things I Saw Today in PsA:Dr. Catherine Bakewell  Do TNFis and JAKis Prevent Cancer!?:Dr. Richard Conway Efficacy and Safety of Nipocalimab for Sjogren's Syndrome:Dr. Mike Putman Evaluating ANA Patterns and Titers with AI:Dr. Bella Mehta Improvements in Pain and Fatigue in Bimekizumab:Dr. Philip Mease  Long Term Follow up from APIPPRA:Dr. Antoni Chan talks with Dr. Andrew Cope Race Neutral PFTs in Scleroderma Improves Equity:Dr. Caoilfhionn Connolly talks with Dr. Kamini Kuchinad  Summary of JAKi Studies:Dr. Peter Nash The Psoriatic March: PsA before PsO:DR. Antoni Chan Use of AI in Hand Ultrasound Scoring:Dr. Bella Mehta  What is MCTD? The Great Debate:Drs. Caoilfhionn Connolly & Lisa Christopher-Stine What's The State of Biosimilars?:Drs. Eric Dein and Jonathan Kay Pred Softly: Steroids:Dr. Jiha Lee talks with Dr. Beth Wallace

Show notes 1. Jeremias S. Strengthening the supply chain: key insights from FDA commissioner Dr Robert Califf. The Center for Biosimilars®. October 25, 2024. Accessed November 1, 2024.  https://www.centerforbiosimilars.com/view/strengthening-the-supply-chain-key-insights-from-fda-commissioner-robert-califf 2. Jeremias S. FDA and industry experts unpack biosimilar device requirements. The Center for Biosimilars. October 23, 2024. Accessed November 1, 2024.  https://www.centerforbiosimilars.com/view/fda-and-industry-experts-unpack-biosimilar-device-requirements 3. Jeremias S. Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims. The Center for Biosimilars. October 23, 2024. Accessed November 1, 2024.  https://www.centerforbiosimilars.com/view/calling-for-unified-biosimilar-standards-stronger-education-at-grx-biosims 4. Jeremias S. Unifying standards: the need for streamlined biosimilar development. The Center for Biosimilars. October 22, 2024. Accessed November 1, 2024.  https://www.centerforbiosimilars.com/view/unifying-standards-the-need-for-streamlined-biosimilar-development 5. Jeremias S. Enhancing Adoption of Infused Biosimilars for a Sustainable Future. The Center for Biosimilars. October 30, 2024. Accessed November 1, 2024.  https://www.centerforbiosimilars.com/view/enhancing-adoption-of-infused-biosimilars-for-a-sustainable-future 6. Jeremias S. IQVIA webinar: enhancing regulatory strategies for biosimilars and generics. The Center for Biosimilars. October 14, 2024. Accessed November 1, 2024.  https://www.centerforbiosimilars.com/view/iqvia-webinar-enhancing-regulatory-strategies-for-biosimilars-and-generics

Send us a textNearly all insured Americans have prescription medication benefits.So why are so many Americans struggling to afford those prescriptions?Shouldn't these benefits cover the cost? In this episode of CareTalk, David Williams speaks with Kyle Kiser, CEO of Arrive Health, to explore the factors driving the disconnect between consumer needs and prescription pricing, and how point-of-prescribing technology can serve as a patient-centered solution. This episode is brought to you by BetterHelp. Give online therapy a try at https://betterhelp.com/caretalk and get on your way to being your best self.As a BetterHelp affiliate, we may receive compensation from BetterHelp if you purchase products or services through the links provided.TOPICS(0:17) Sponsorship(2:01) Why Is Medication Access an Issue?(4:23) What Happened to Affordable Medicine?(5:14) The State of Prior Authorization(7:08) Why Hasn't Electronic Prescribing Solved Consumer Constraints?(8:58) What Is Patient-Centered, Provider-Friendly Tech?(13:18) The Issues with Preferred Pharmacies(15:34) How Have Pharma Support Programs Evolved?(18:12) The Role of Biosimilars in Reducing Prices(19:38) What Should a Patient Know When Dealing with Prescription Costs?

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.This week's commercialization news includes updates on Zepbound supply, Enjaymo's new home, and expanding access to HIV drugs. Medicare has tweaked rules for drug price talks, while GSK reports that its RSV vaccine protects against disease over three seasons. GSK's Viiv plans to expand the supply of HIV drugs in Africa, and Sanofi's rare disease drug finds a new home at Recordati. Other news includes a protein prediction winning the Chemistry Nobel and Alnylam submitting an important drug application. Trends suggest that biosimilars may make a mark in 2025, with incentives favoring them in the Medicare market. Protein prediction wins the Chemistry Nobel Prize, Alnylam submits a crucial drug application, Lilly partners with AI specialist Insitro to develop metabolic medicines, and Purespring raises $105 million for gene therapy for kidney disease. AI startup Basecamp allies with The Broad Institute to create 'programmable' genetic medicines. Additionally, Lilly appoints Mount Sinai scientist Thomas Fuchs as its first Chief AI Officer to lead AI initiatives in drug discovery and clinical trials. Other news includes J&J closing a cancer study, Alnylam seeking approval for a potential blockbuster drug, and Propharma receiving a regulatory and compliance award at CPhI.The Supreme Court declined to review a Texas abortion case related to emergency care, a blow to the Biden administration's efforts. A survey found that nearly 70% of healthcare organizations affected by cyberattacks experienced disruptions in patient care. Steward Health Care is auctioning off assets, including closing Norwood Hospital in Massachusetts. Baxter reported no structural damage at their North Carolina site affected by Hurricane Helene. The payer-provider relationship in healthcare is becoming more complex with consolidation and value-based care, leading to tensions over reimbursement and access.Kezar's lupus trial has been put on hold after four patient deaths, making it a potential buyout target. Investor Kevin Tang is interested in acquisition. Big pharma is also investing in cell and gene therapies, with companies like Lilly and Sanofi making moves in the industry. The Genscript Biotech Global Forum 2025 is coming up on January 15, offering a platform to discuss innovations and challenges in gene and cell therapy. Additionally, Lilly's obesity clinical program faces challenges, while Stealth's ultrarare disease candidate may not meet approval standards.Eli Lilly's obesity program is highlighted as a key factor in the company's dominance in the industry, with CEO David Ricks confident in their position. Wuxi Biologics faces uncertainty in the U.S. after setbacks, while big pharma companies show growing interest in cell and gene therapy. Five radiopharma biotechs are identified as potential buyout targets, and Trilink Biotechnologies introduces custom sets of mRNA for screening studies. Other news includes increased investment in cell and gene therapy, activist investor Starboard's stake in Pfizer, and Merck's success with Keytruda in head and neck cancer. AstraZeneca puts $2 billion towards heart disease drugs, Sanofi offloads a rare autoimmune drug, and AbbVie trims earnings guidance.

Show notes 1. FDA Approves Pavblu for Retinal Conditions 2. AAM Report: Generics and Biosimilars Savings Reach $445 Billion in 2023, Part 1 3. Expanding Biosimilar Adoption: Insights and Strategies With Dr Sophia Humphreys 4. The Future of Biosimilar Gene Therapies: Key Issues and Potential 5. IRA Reimbursement Impact on Biosimilars Minimal Despite Rising Market Share 6. The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings 7. France Study Finds High Patient Satisfaction With Adalimumab Biosimilar Treatment for IBD

On today's episode, we are thrilled to discuss an important and often misunderstood area of oncology: Biosimilars and their increasing use in cancer care.You might be curious, what exactly are biosimilars? How are they developed and approved? And most importantly, how are they transforming the lives of patients diagnosed with cancer? We will break down these questions and more with an overview from Dr. Julie Gralow, a breast medical oncologist and chief medical officer at the American Society of Clinical Oncology.

Show notes 1. Sandoz Reports 29% Growth in Biosimilar Revenues for First Half of 2024 2. Pure-Play Biosimilar Company Reports 10-Fold Revenue Increase for First Half of 2024 3. Formycon Reports €26.9 Million Revenue for First Half 2024, Driven by Biosimilars 4. CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel 5. FDA Approves Biosimilar Enzeevu for Eye Conditions 6. Manitoba Adopts Biosimilar Switching Policy 7. Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results 8. Vizient Report Projects Price Inflation for Originators With Biosimilars in the Pipeline

Show notes 1. FDA Approves Samsung Bioepis' Pyzchiva, a Biosimilar to Stelara 2. Ahzantive Receives FDA Approval as New Eylea Biosimilar 3. FDA Approves Epysqli as Second Soliris Biosimilar 4. BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed 5. Biosimilars and Employers: Strategies for Success 6. Learning the Lingo of Biologics and Biosimilars Is Critical 7. Singapore Experience Shows Benefits of Value-Driven Strategies in Generating Biosimilar Savings 8. Approximately Half of Patients Demonstrated Poor Health Literacy Prior to Biosimilar Switch

Show notes To learn more about Cencora and their efforts, click here. To learn more about the Inflation Reduction Act's impact on biosimilars, click here.

Show notes 1. Biosimilars Check-In: Application Acceptances, European Approvals, New Partnerships 2. Overcoming Economic, Noneconomic Barriers to Biosimilar Adoption in Oncology 3. EHA 2024: Rituximab Biosimilars Improve Quality of Life, Infusion-Related Reactions 4. New Data Show Safety of Ado-Trastuzumab, Trastuzumab Biosimilars in HER2+ Cancers 5. ASCO Posters Reflect on Reimbursement Trends, Combination Therapies Involving Biosimilars 6. ASCO 2024 Posters Showcase Positive Data on Denosumab, Pegfilgrastim Biosimilars 7. Authors Spotlight Long-Term Solutions to Ensure Biosimilar Market Sustainability 8. Part 2: Unlocking the Potential of Biosimilars to Improve Health Equity

Drs. David Eichenbaum and Priya Vakharia share their insights on biosimilars in the treatment of retinal disease in the United States.

On a December morning, a 62-year-old goes for a walk. There's snow on the ground and she loses her balance. She falls and fractures her wrist. This simple fracture reveals underlying osteoporosis, requiring lifelong (and expensive) medication. But as you'll learn from Dr. Richard Eastell, an endocrinologist and professor of Bone Metabolism at the University of Sheffield, this is where biosimilars come in. Biosimilars are extremely similar — hence the name — to the original biological drug they're designed to imitate. The excitement around biosimilars is that they're cheaper, making them more accessible to more people, meaning fewer fractures … better health … a better economy … and ultimately, a better quality of life.

Pediatricians, families, and pharmacists are faced with increasing drug costs and a vast array of complex biologic therapies. Up-to-date knowledge on prescribing practice is constantly a need, specifically regarding generics and the availability of biosimilar and interchangeable biosimilar agents. According to a report from the Association for Accessible Medicines, the U.S. healthcare system saved $408 billion from using generic and biosimilar drugs in 2022, a huge jump from the $195 billion in savings accumulated in 2013. In today's episode, we have a rare opportunity to learn critical knowledge about this topic from renowned experts in the field.  We are joined by John Routt Reigart, MD, and Dr. Siu. Dr. Reigart is professor emeritus at the Medical University of South Carolina as well as the chairperson for the American Academy of Pediatrics' (AAP) Committee on Drugs. “I have been recognized in my state, and to some extent nationally, as being an advocate for improved health for children. I feel that it's very important that pediatricians be advocates for effective regulations for their patients,” Dr. Reigart says.  Dr. Siu is a clinical professor, the vice chair for teaching and learning, and the director of faculty mentoring at the Ernest Mario School of Pharmacy at Rutgers University. She is a pediatric pharmacy clinical coordinator and practices at the K. Hovnanian Children's Hospital and Jersey Shore University Medical Center. She has also been appointed to the board of directors of the Board of Pharmacy Specialties and the pediatric pharmacy association liaison for the AAP Section on Clinical Pharmacology and Therapeutics executive committee. “We want to make sure that medications are easily accessible to families and we also want to make sure that they are also cost effective,” Anita Sui, PharmD, says.  This episode was recorded at the 2023 American Academy of Pediatrics National Conference and Exhibition. Some highlights from this episode include:  The difference between biologics and generics  What the orange and purple books are and their roles in the industry  What an interchangeable product is  Patents and exclusivity  What savings could look like with an uptick of biologics and generics    For more information on Children's Colorado, visit: childrenscolorado.org