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To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, click here .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 B...

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...

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...

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...

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 Cen...

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 B...

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 fo...

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 Strat...

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. Man...

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 Experien...

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, C...

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 Stud...

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 Bi...

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 Effect...

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 ab...

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...

For more information on BsUFA III, click here . For more information on the 1-year anniversary of adalimumab biosimilars in the US, click here . To listen to more of Julie Reed's thoughts on the US biosimilar industry and streamlining development, click here .  To learn more about the Biosimilars Forum, click here .

Happy Birthday Adalimumab Biosimilars: Reflecting on the First Year of US Competition EMA Approves First Ustekinumab Biosimilar, Uzpruvo Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe IQVIA Projects $192 Billion Loss for Originators by 2028 Thanks to Biosimilar, Generic Compe...

Show notes To learn more about the prospect for Neulasta OnPro biosimilars, click here . To learn more about how the IRA will impact biosimilars, click here .  To learn more about the dual-pricing strategy being used for adalimumab biosimilars, click here . To hear Brian's insight into how the ophthalmology biosimilar industry is developing, click here . To listen to previous Not So Different epis...