Podcasts about 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

Amy Williams from Skellig Automation joins hosts Phil Seboa and Ed Fuentes to dive into the world of industrial IoT and automation in life sciences. Learn about Amy's journey into life sciences, challenges in the pharmaceutical industry, and the potential of digital tools like the Unified Namespace and Industry 4.0. Discover how new technologies are improving data management and making healthcare more accessible. Tune in for an inspiring conversation on the future of life sciences and the digital revolution. 00:00 Introduction and Welcome 00:30 Introduction of Amy Williams 01:45 Amy's Background in Life Sciences and Automation 05:32 Paper vs. Digital Workflow in Pharmaceuticals 08:40 Insights on Graph Databases 10:50 GraphQL and Database Automation 13:00 The Future Landscape of Tech in Life Sciences 15:12 The Role of Biosimilars in Healthcare 17:35 Addressing US Drug Shortages 20:05 Skellig's Initiatives in Supply Chain Digitalization 22:16 Challenges in Technology Adoption 24:40 Amy's Influences and Family Background 27:00 From College to Automation Engineering 30:15 Transitioning to Life Sciences 33:03 Personal Health Journey and its Impact 36:22 Making Healthcare More Accessible 38:40 Inefficiencies in Manufacturing and Costs to Patients 42:10 Advocacy for Industry Change 44:00 Upcoming News on Industry Innovations 46:30 Advice for Embracing Industry 4.0 49:00 Conclusion and Final Thoughts Connect with Amy on LinkedIn: https://www.linkedin.com/in/amy-williams-a8974b114/ Connect with Phil on LinkedIn: https://www.linkedin.com/in/phil-seboa/ Connect with Ed on LinkedIn: https://www.linkedin.com/in/ed-fuentes-2046121a/ About Industry Sage Media: Industry Sage Media is your backstage pass to industry experts and the conversations that are shaping the future of the manufacturing industry. Learn more at: http://www.industrysagemedia.com

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

In this episode of HR Benecast, Mike Stull and Eric Dublikar cover your pharmacy and employee benefits questions including:   What's new in federal and state pharmacy benefit legislation. How Employers Health is working to help clients manage changes to their PBM plans.  What the switch to biosimilars for Humira and Stelara means for plan sponsors?  What impact are GLP-1s having on employer drug spend? Trends in GLP coverage for weight loss.

Biologics are complex, high-cost treatments derived from living systems, used for immune-related disorders. Biosimilars are more affordable alternatives that are highly similar to biologics, with no significant clinical differences. The FDA supports biosimilar development to reduce costs, and various financial aids are available to help patients access these treatments. Join us as we discuss these important topics. CME Credit Available:  https://uiowa.cloud-cme.com/course/courseoverview?P=0&EID=67816  Host: Gerard Clancy, MD Senior Associate Dean for External Affairs Professor of Psychiatry and Emergency Medicine University of Iowa Carver College of Medicine Guests: Brittany Bettendorf, MD Associate Professor of Rheumatology University of Iowa Carver College of Medicine Ashlyn Johnson, PharmD Pharmacy Specialist Inflammatory Bowel Disease Treatment Team University of Iowa Hospitals & Clinics Financial Disclosures:  Dr. Gerard Clancy, his guests and the members of the planning committee for Rounding@IOWA have no relevant financial relationships to disclose. CME Credit Designation: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this enduring material for a maximum of 0.75 AMA PRA Category 1 CreditTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Pharmacist: The University of Iowa Roy J. and Lucille A. Carver College of Medicine designates this knowledge-based activity for a maximum of 0.75 ACPE contact hours. Credit will be uploaded to the NABP CPE Monitor within 60 days after the activity completion. Pharmacists must provide their NABP ID and DOB (MMDD) to receive credit.  UAN: JA0000310-0000-24-070-H01-P Other Health Care Providers: A certificate of completion will be available after successful completion of the course. (It is the responsibility of licensees to determine if this continuing education activity meets the requirements of their professional licensure board.)  

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

To learn more about the approval of denosumab-bddz, click here. To watch Curtis and Edgerton speak on the approval of denosumab-bddz and osteoporosis treatment, click here. To learn more about the ROSALIA study (NCT05405725), click here.  Extra content: To read more about the Biosimilars Council position paper on how to improve biosimilar development, click here.

Do you know how to have a heads-up conversation about biosimilars?  Credit available for this activity expires: 6/6/25 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/1001162?ecd=bdc_podcast_libsyn_mscpedu

What are the main indicators that a patient with multiple sclerosis (MS) can be switched to a biosimilar?    Credit available for this activity expires: 5/31/2025 Earn Credit / Learning Objectives & Disclosures: https://www.medscape.org/viewarticle/1000864?ecd=bdc_podcast_libsyn_mscpedu

The Cochrane Eyes and Vision US Project prepares and maintains reviews across a wide range of conditions. These include neovascular age-related macular degeneration and their new review of its treatment by anti-vascular endothelial growth factor biosimilars was published in June 2024. Here's one of the authors, Sueko Ng from the Department of Ophthalmology in the University of Colorado Anschutz Medical Campus in the USA, to tell us more about the condition and this treatment.

The Cochrane Eyes and Vision US Project prepares and maintains reviews across a wide range of conditions. These include neovascular age-related macular degeneration and their new review of its treatment by anti-vascular endothelial growth factor biosimilars was published in June 2024. Here's one of the authors, Sueko Ng from the Department of Ophthalmology in the University of Colorado Anschutz Medical Campus in the USA, to tell us more about the condition and this treatment.

Show notes FDA Approves High-Concentration Cyltezo Eye on Pharma: Simlandi US Launch; Ranibizumab Partnership; Expanded Access for Adalimumab Biosimilars DDW 2024 Posters Evaluate Safety, Efficacy, Impact of BMI on Zymfentra Use Posters Demonstrate Switching Safety Between Originator, Biosimilar Infliximab in IBD New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment

The Cochrane Eyes and Vision US Project prepares and maintains reviews across a wide range of conditions. These include neovascular age-related macular degeneration and their new review of its treatment by anti-vascular endothelial growth factor biosimilars was published in June 2024. Here's one of the authors, Sueko Ng from the Department of Ophthalmology in the University of Colorado Anschutz Medical Campus in the USA, to tell us more about the condition and this treatment.

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

Self-administered device cleared to treat stress urinary incontinence in women; Autoinjector warning for relapsing MS treatment; COVID-19 preexposure prophylaxis investigational treatment looks promising; Biosimilars for Eylea approved; Imdelltra approved for extensive stage small cell lung cancer with disease progression.  

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

Show notes To read our coverage of the Cardinal Health report, click here. To read the full report, click here. To check out The Center for Biosimilars coverage of Festival of Biologics USA, click here.

Show notes FDA Approves Henlius' Trastuzumab Biosimilar, Hercessi Alvotech's Stelara Biosimilar, Selarsdi, Receives FDA Approval Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar AON Saves Over $243 Million With High Biosimilar Adoption Julie Reed: Why 2024 Is Important for Biosimilars The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion Review Highlights Most Popular European Policies to Boost Biosimilar Uptake

Welcome to the 31st episode in my drug name pronunciation series.  Today, we're talking about tocilizumab-aazg, Tyenne ®, and Actemra®.    In this episode, I divide all three drug names into syllables, talk about tocilizumab's suffix, tell you which syllables to emphasize, and share my sources. The written pronunciations can be helpful, so you can see them below and in the show notes on thepharmacistsvoice.com.   tocilizumab-aazg - TOE si LIZ ue mab A-A-Z-G (Say one letter at a time for “aazg.") Emphasize TOE and LIZ.  Emphasize LIZ the most.   Sources:  USP Dictionary Online and Fresenius Kabi Media Relations    Tyenne = Tye-EN  Emphasize EN Source:  Medication Guide for Tyenne   Actemra = AC-TEM-RA  No syllable is emphasized.   Source: Medication Guide for Actemra   Thank you for listening to episode 276 of The Pharmacist's Voice ® Podcast!   To read the FULL show notes, visit https://www.thepharmacistsvoice.com.  Click the Podcast tab, and select episode 276.   Subscribe to or follow The Pharmacist's Voice ® Podcast to get each new episode delivered to your podcast player and YouTube every time a new one comes out!     Apple Podcasts   https://apple.co/42yqXOG  Spotify  https://spoti.fi/3qAk3uY  Amazon/Audible  https://adbl.co/43tM45P YouTube https://bit.ly/43Rnrjt   Links from this episode The Ohio Pharmacist's Association https://www.ohiopharmacists.org  FDA Purple Book https://purplebooksearch.fda.gov/  Choosing a suffix:  https://www.fda.gov/files/drugs/published/Nonproprietary-Naming-of-Biological-Products-Guidance-for-Industry.pdf (see page 10) USP Dictionary Online (aka “USAN”)  **Subscription-based resource USP Dictionary's (USAN) pronunciation guide (Free resource on the American Medical Association's website) The Pharmacist's Voice ® Podcast Episode 274, pronunciation series episode 30 (citalopram and escitalopram) The Pharmacist's Voice ® Podcast Episode 272, pronunciation series episode 29 (losartan) The Pharmacist's Voice Podcast Episode 269, pronunciation series episode 28 (tirzepatide) The Pharmacist's Voice Podcast Episode 267, pronunciation series episode 27 (atorvastatin)  The Pharmacist's Voice Podcast Episode 265, pronunciation series episode 26 (omeprazole) The Pharmacist's Voice Podcast Episode 263, pronunciation series episode 25 (PDE-5 inhibitors) The Pharmacist's Voice Podcast Episode 259, pronunciation series episode 24 (ketorolac) The Pharmacist's Voice ® Podcast episode 254, pronunciation series episode 23 (Paxlovid) The Pharmacist's Voice ® Podcast episode 250, pronunciation series episode 22 (metformin/Glucophage) The Pharmacist's Voice Podcast ® episode 245, pronunciation series episode 21 (naltrexone/Vivitrol) The Pharmacist's Voice ® Podcast episode 240, pronunciation series episode 20 (levalbuterol) The Pharmacist's Voice ® Podcast episode 236, pronunciation series episode 19 (phentermine)  The Pharmacist's Voice ® Podcast episode 228, pronunciation series episode 18 (ezetimibe) The Pharmacist's Voice ® Podcast episode 219, pronunciation series episode 17 (semaglutide) The Pharmacist's Voice ® Podcast episode 215, pronunciation series episode 16 (mifepristone and misoprostol) The Pharmacist's Voice ® Podcast episode 211, pronunciation series episode 15 (Humira®) The Pharmacist's Voice ® Podcast episode 202, pronunciation series episode 14 (SMZ-TMP) The Pharmacist's Voice ® Podcast episode 198, pronunciation series episode 13 (carisoprodol) The Pharmacist's Voice ® Podcast episode 194, pronunciation series episode 12 (tianeptine) The Pharmacist's Voice ® Podcast episode 188, pronunciation series episode 11 (insulin icodec)  The Pharmacist's Voice ® Podcast episode 184, pronunciation series episode 10 (phenytoin and isotretinoin) The Pharmacist's Voice ® Podcast episode 180, pronunciation series episode 9 Apretude® (cabotegravir) The Pharmacist's Voice ® Podcast episode 177, pronunciation series episode 8 (metoprolol)  The Pharmacist's Voice ® Podcast episode 164, pronunciation series episode 7 (levetiracetam) The Pharmacist's Voice ® Podcast episode 159, pronunciation series episode 6 (talimogene laherparepvec or T-VEC)  The Pharmacist's Voice ® Podcast episode 155, pronunciation series episode 5 Trulicity® (dulaglutide)  The Pharmacist's Voice ® Podcast episode 148, pronunciation series episode 4 Besponsa® (inotuzumab ozogamicin) The Pharmacist's Voice ® Podcast episode 142, pronunciation series episode 3 Zolmitriptan and Zokinvy The Pharmacist's Voice ® Podcast episode 138, pronunciation series episode 2 Molnupiravir and Taltz The Pharmacist's Voice ® Podcast episode 134, pronunciation series episode 1 Eszopiclone and Qulipta

2024 Global Generics & Biosimilars Awards by Citeline

Biosimilars in retina are here. How are practices integrating them into their clinics? And how do they navigate issues around payer policy, protocol changes, and ensuring continuity of care?  Moderator John Kitchens, MD, sits down with retina specialist Dave Brown, MD, and Kristin Yockus, the VP of Process Integrations at Retina Consultants of America, to answer these questions, and to preview how the coming increase in biosimilar options might play out in a real-world landscape. 

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.

Show notes AAD Posters Examine Clinical Effects of Switching to Ustekinumab, Adalimumab Biosimilars Posters From AMCCBS and AAD Showcase New Technology for Biosimilar Uptake, Barriers to Self-Injectable Biologics Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake Adalimumab Expenditures in Countries With and Without Available Biosimilars Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5 Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs Cardinal Health Report Showcases Biosimilar Growth, Provider and Payer Evolution, and More

Show notes To read more of Ha Kung's thoughts on the US patent system and its role in the biosimilar landscape, click here. To learn more about Congress' role in addressing AbbVie's alleged anticompetitive practices regarding adalimumab products, click here. To learn more about the suit filed by CareFirst BlueCross BlueShield regarding ustekinumab biosimilar delays, click here. To learn more about the settlements that have resulted in the market delay of ustekinumab biosimilars, click here. To learn more about lawsuits involving AbbVie that led to the delayed market entrance of adalimumab biosimilars, click here. To learn more about what types of patents are at most to blame for biosimilar market delays, click here.

The 1984 Hatch-Waxman Act codified the 505(b)(2) drug approval pathway and allowed the use of studies from a previously approved drug. To be clear, medications approved via this pathway are not generic molecules of the reference listed drug. They may have similar clinical effects and roles in therapy, but they also bring challenges. Dr. Tyler Wood, System Director of Pharmacy Oncology and Biosimilars, and Pharmacy Executive Director, Carolyn Liptak at Vizient, join Gretchen Brummel, Pharmacy Executive Director in the Vizient Center for Pharmacy Practice Excellence and your program host to give an early look.   Guest speakers:  Tyler Wood, PharmD, BCBBS System Director, Pharmacy Oncology and Biosimilars  Providence St. Joseph Health Carolyn Liptak, MBA, BSPharm Pharmacy Executive Director  Vizient    Host:  Gretchen Brummel, PharmD, BCPS  Pharmacy Executive Director  Vizient Center for Pharmacy Practice Excellence    Show Notes:  [00:55-01:34] Dr. Tyler Wood background information  [01:35-03:09] How the 505(b)(2) pathway is intended to work [03:10-04:32] Comparisons can we draw from the biologics approval process [04:33-05:53] What the FDA says about which pathway to use [05:54-07:05] What's changed recently in the approval process [07:06-08:09] Can a 505(b)(2) product be rated as a generic equivalent? [08:10 -09:07] How CMS changes are impacting management [09:08-11:23] What our providers can do to plan and act to address these issues [11:24-12:27] What's most concerning moving forward   Links | Resources:  Applications Covered by 505(b)(2) Hospital Outpatient Prospective Payment System: January 2024 Update MLN Matters® Articles Sign-up CMS.gov ASP Pricing Files CMS.gov What's a MAC Drugs@FDA: FDA-Approved Drugs FDA: Overview of the 505(b)(2) Regulatory Pathway for New Drug Applications HCPCS Level II Coding for 505(b)(2)-Approved Drugs or Biologicals – Frequently Asked Questions   Subscribe Today! Apple Podcasts Amazon Podcasts Google Podcasts Spotify Android RSS Feed  

Show notes FDA Approves 10th Adalimumab Biosimilar, Simlandi Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates Vizient Report Emphasizes Biosimilar Successes, Impact of Inflation on Drug Spend Eye on Pharma: VA Picks Hadlima; Biocon, Sandoz Partnership; A Stelara Settlement Abroad Eye on Pharma: Celltrion Biosimilars Win Tenders; Oral Ustekinumab Device Passes Phase 1 Trial Analyzing Safety of Switching From Originators to Biosimilars: A Meta-Analysis of 21 Trials Adalimumab Treatment May Impact Antibody Levels After COVID-19 Vaccination

Biosimilars are entering the market at their fastest pace ever. In this episode, we interview a renowned health economist and an expert consultant in biosimilar distribution and patient support to explore the complex landscape of biosimilars, including examining the hurdles and breakthroughs in achieving acceptance by payers and providers and how best to improve patient access and affordability in a market dominated by established brands. Dr. Jason Shafrin, Senior Managing Director, Center for Healthcare Economics and Policy at FTI Consulting Marina Allen, SVP, Fingerpaint Market Access, Patient Support & Access Strategy Leader in Pharma-Biotech Biosimilars The Biologics Price Competition and Innovation Act of 2009 PBMs (Pharmacy Benefit Managers) Medicare Advantage Humira (biosimilars) 340B program Inflation Reduction Act Medicare Part D "brown bagging and white bagging" Mark Cuban (CostPlusDrugs) GoodRx average sales price (ASP) electronic health record (EHR) system Questions or comments?Email us at comments@prescriptionforbetteraccess.com.Find us on social media! Follow us on X, LinkedIn, YouTube and Threads.

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    

On episode 456 of The Nurse Keith Show nursing and healthcare career podcast, Keith interviews seasoned biopharmaceutical executive Janice Nissen, BSN, MBA, MS and William Soliman, PhD, BCMAS, the Founder and CEO of the Accreditation Council for Medical Affairs (ACMA). In the course of their conversation, Keith and his guests discuss the plethora of career opportunities in the life science industry — including pharma and biotech — that ambitious and curious nurses can take advantage of when seeking new professional avenues of endeavour. Also discussed are the changes that the pharmaceutical industry has undergone in recent years, and how situations around the globe, such as the war in Ukraine, can directly impact the availability of many commonly used medications. Dr. William Soliman is the Founder and CEO of the Accreditation Council for Medical Affairs (ACMA). He is considered by many to be a pharma industry futurist. With over 15 years of experience in the pharmaceutical industry working with several companies such as Merck, Abbvie, Gilead Sciences and Eisai and others, Dr. Soliman is passionate about transforming the industry through benchmarking and technology. ACMA is most well-known for the Board Certified Medical Affairs Specialist (BCMAS) program which is the first and only board certification for MSL and Medical Affairs Professionals in the world. The ACMA also works within the market access space offering the Prior Authorization Certification Specialist (PACS) program and the Biologics & Biosimilars area with the first Board Certification offered in this field. Janice Nissen is a healthcare professional and a seasoned biopharmaceutical executive who has developed commercialization strategies at two multinational pharmaceutical companies, Merck, and Abbott Laboratories. This work included numerous first-in-class products with market leadership and favorable outcomes for patients. She led an enterprise-wide, global strategy of incorporating patient input into the companies' value chain, from discovery through patent expiry, resulting in products that were more relevant, valued, and accessible.  Jan is currently consulting with the NIH Foundation on patient engagement strategies to support their public-private partnerships, and building a first of its kind educational curriculum for nurses interested in a life science career with the Accreditation Council for Medical Affairs. She is also serving as an advisor to Press Ganey on customer experience in clinical trials. Connect with Dr. William Soliman and Janice Nissen: ACMA Dr. Soliman on TikTok Dr. Soliman on LinkedIn NursetoPharma.org Janice Nissen on LinkedIn ----------- Did you know that you can now earn CEUs from listening to podcasts? That's right — over at RNegade.pro, they're building a library of nursing podcasts offering continuing education credits, including episodes of The Nurse Keith Show! So just head over to RNegade.pro, log into the portal, select Nurse Keith (or any other Content Creator) from the Content Creator dropdown, and get CEs for any content on the platform! Nurse Keith is a holistic career coach for nurses, professional podcaster, published author, award-winning blogger, inspiring keynote speaker, and successful nurse entrepreneur. Connect with Nurse Keith at NurseKeith.com, and on Twitter, Facebook, LinkedIn, and Instagram. Nurse Keith lives in beautiful Santa Fe, New Mexico with his lovely fiancée, Shada McKenzie, a highly gifted traditional astrologer and reader of the tarot. You can find Shada at The Circle and the Dot. The Nurse Keith Show is a proud member of The Health Podcast Network, one of the largest and fastest-growing collections of authoritative, high-quality podcasts taking on the tough topics in health and care with empathy, expertise, and a commitment to excellence. The podcast is adroitly produced by Rob Johnston of 520R Podcasting, and Mark Capispisan is our stalwart social media ringmaster and newsletter wrangler.