Not So Different: A Podcast from The Center for 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To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, click here.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.

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

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

 Show notes  To learn more about the 10th anniversary of the first FDA biosimilar approval, click here.  To learn more about how much biosimilars have saved so far, click here.  To read more about Josh's views on the pharmaceutical landscape in 2025, click here. 

 Show notes  To learn more about the FTC's most recent report on PBMs, click here.  To learn more about the FTC's first report on PBMs, click here.  To learn more about health care actions taken by the second Trump Administration during it's first month, click here.  To learn more about the views of Mehmet Oz, MD (more commonly known as Dr. Oz) on price transparency ahead of his congressional confirmation hearings as President Trump's nominee for HHS Secretary, click here. 

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

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-

Show notes To learn more about GBW, click here. To check out our coverage of the recent GRx+Biosims conference Craig mentioned, click here. To learn more about product hopping, click here. To read part 1 of our GBW series, click here. To read part 2 of our GBW series, click here. To read part 3 of our GBW series, click here. To hear another episode featuring more of Craig's thoughts on the Biden's administration's impact on the biosimilar industry, click here.

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

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

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

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.

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

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

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