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 …

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 Re…

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 expa…

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…

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 unp…

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…

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 App…

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…

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.Af Not So Different: a Podcast from The Center for Biosimilars

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 …

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 developmen…

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 Biosimil…

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.Af Not So Different: a Podcast from The Center for Biosimilars

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 Fac…

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 Biosi…

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 …

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 Tend…

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 Origi…

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…

Show notes To learn more about the FDA approval of Zymfentra, click here. To learn more about the results from the LIBERTY trials, click here.Af Not So Different: a Podcast from The Center for Biosimilars

Show notes Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle? Part 1: Oncology Biosimilars Offer Comparable Benefits to Originators at Lower Prices Part 2: French Study Finds Trastuzumab Biosimilar Program Could Generate Meaningful Savings Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Eu…

Show notes For more information on Global Biosimilars Week, click here. To read our article series in honor of Global Biosimilars Week, you can check out part 1, part 2, and part 3 here. To watch the webinar The Center for Biosimilars collaborated with IGBA for Global Biosimilars Week, click here.Af Not So Different: a Podcast from The Center for Biosimilars

FDA Approves First Subcutaneous Infliximab Product Abrilada Approved as Second Interchangeable Humira Biosimilar Eye on Pharma: New GI Data and Byooviz Interchangeability Propel Biosimilars Into the Future Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart Eye on Pharma: Another CRL for Alvotech; Cim…

Show Notes House Committee Hearing Addresses PBMs, Anticompetitive Drug Pricing Tactics Part 2: FDA Workshop Shares Manufacturer Perspective on the Value of Clinical Efficacy Testing Part 1: FDA Workshop Highlights Global Regulatory View on Biosimilar Development Part 3: BioRationality—FDA Webinar on Biosimilars Efficacy Testing Marks Major Step Fo…

To read more about Dr. Gregory's commentary piece, click here. To read more about Cardinal Health's 2023 Biosimilars Report, click here. To learn more about adalimumab biosimilars, click here. To learn more about the adalimumab biosimilars that have launched so far in the US: Click here for the launch of Amjevita Click here for the launches of Hyri…

Show Notes FDA Approves First MS Biosimilar Stelara and Enbrel Chosen for IRA Price Negotiation Biocon Biosimilar Quarterly Sales Up 106% STADA Earnings Project Record Breaking Profits for 2023 Despite Global Increase in Amjevita Sales, US Sales Dropped 63% Authors Suggest Major Policy Shifts to Boost Biosimilar Development, Accessibility Cardinal …

Show notes To read CFB's analysis of the paper, click here. To view the full version of the paper, click here. To learn more about the Biosimilars Forum and its members, click here. To read the IQVIA report cited in the paper, click here. To read the IQVIA report cited in the paper, click here.Af Not So Different: a Podcast from The Center for Biosimilars

Show Notes First Round of Adalimumab Biosimilar Launches in July Celltrion Launches Yuflyma on the US Market US Welcomes Idacio, Hulio to the Adalimumab Biosimilar Market Will the Entry of Adalimumab Biosimilars to the US Market Successfully Lower Spending? Contributor: Self-Administered Biosimilars Are Coming Quickly—Is Your Clinic Ready? Despite …

Show notes To learn more about the adalimumab products that have launched in the US so far, click here, here, here, or here. Crohn's & Colitis Educational Resources: Biosimilars: What You Should Know What is a Biosimilar VideoAf Not So Different: a Podcast from The Center for Biosimilars

Show notes Mark Cuban’s Online Pharmacy Partners With Coherus Biosciences for Humira Biosimilar Roundup: Coherus Resolves AbbVie Dispute; Bio-Thera Solutions and Celltrion Expand Respective Partnerships Eye on Pharma: First PBM to Cover Yusimry; Celltrion to Test Ocrevus Biosimilar; Another Stelara Settlement The Age of Adalimumab Is Upon Us: How S…

Show Notes FDA Approves Celltrion’s Yuflyma, the Ninth Adalimumab Biosimilar Celltrion Launches Biobetter in Brazil, Shares Phase 3 Plan for MS Biosimilar Amgen’s Stelara Biosimilar Delayed Until 2025 After Settling With J&J Dr Colby Evans: The Managed Care Perspective on Biosimilars in Immunology Dr Vibeke Strand: The Current State of Immunology B…

To learn more about Tasmina's Asembia 2023 presentation, click here. Check out the full AmerisourceBergen Biosimilar pipeline report. To listen to Brian's past appearance on Not So Different, click here.Af Not So Different: a Podcast from The Center for Biosimilars

Show notes To read all the articles within the supplement, click here. To read the article references in this episode, click here.Af Not So Different: a Podcast from The Center for Biosimilars

Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval FDA Issues Another CRL for Alvotech’s Adalimumab Biosimilar Multiple Infliximab Biosimilar Switches Appear Safe, Effective for Patients With IBD Study on Nonmedical Switching for Adalimumab Biosimilars Warns About Nocebo Effect Spherix Global Insights: Despite High Awareness, Pr…

To learn more about biosimilars to treat RA, click here. To learn more about rheumatologists’ perceptions about RA biosimilars, click here. To learn more about incentives for prescribing biosimilars, click here. To learn more about infliximab biosimilar adoption, click here. To learn more about the influx of adalimumab biosimilars to the US market,…

Show notes Canadian Province Newfoundland and Labrador Adds Biosimilar Switching Policy Yukon Becomes Tenth Canadian Jurisdiction to Add Biosimilars Switching Policy Policy Recommendations for Improving Biosimilar Uptake in Belgium Researchers Recommend Improvements for China’s Biosimilar Regulatory Policies Dr Ivo Abraham Column: The 2022 WHO Bios…

Show notes To listen to our podcast with Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars, click here.Af Not So Different: a Podcast from The Center for Biosimilars

Show notes Eye on Pharma: Formycon Aflibercept Data; Sandoz CHMP Nod; Henlius Daratumumab Study https://www.centerforbiosimilars.com/view/eye-on-pharma-formycon-aflibercept-data-sandoz-chmp-nod-henlius-daratumumab-study Report: Over 60% of Providers Plan to Only Prescribe Interchangeable Adalimumab Biosimilars https://www.centerforbiosimilars.com/v…

Show notes To learn more about Vizient’s Pharmacy Outlook Report, click here. To read Dr. Dolan’s paper “Opportunities and Challenges in Biosimilar Uptake in Oncology published in The American Journal of Managed Care®, click here. To read Dr. Dolan’s paper “Evolving Practices in Managing Costly Immunotherapy” published in The American Journal of Ma…

Show notes US Welcomes First Adalimumab Biosimilar, Amjevita https://www.centerforbiosimilars.com/view/us-welcomes-first-adalimumab-biosimilar-amjevita Canada Approves High-Concentration Humira Biosimilar https://www.centerforbiosimilars.com/view/canada-approves-high-concentration-humira-biosimilar Celltrion Submits BLA for Infliximab Biobetter htt…

Show notes: To check out part 1 of this interview series (written Q&A with Samsung Bioepis’ Kyung-Ah Kim), click here. Coming soon, part 3 will be a video interview about the initial market response to ophthalmology biosimilars and how industry leaders can work together to increase uptake. To learn more about the approval of Cimerli, click here. To…

Top 10 stories of the year: 10. FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar 9. Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA 8. AbbVie Settles ITC Case With Alvotech; Humira Biosimilar to Launch July 2023 7. Review: Biobetters and Biosimilars Set to Emerge in Ophthalmology 6. Report: Biosimil…

To read more about adalimumab biosimilars, click here. To read more about ophthalmology biosimilars, click here. To learn more about the Inflation Reduction Act’s impact on biosimilars, click here. To read more about the reauthorization of the Biosimilars User Fee Amendment, click here. To learn more about interchangeability, click here.…

Show notes Rezvoglar Becomes Second Interchangeable Insulin Biosimilar Biosimilar Business Recap: Progress for Insulin in Europe, Canada; Biocon Biologics' Viatris Acquisition Completed The European Union Gains Another Ranibizumab Biosimilar Alvotech Snags Australian Approval for Adalimumab Biosimilar Biosimilar Check-in: PBM to Cover Adalimumab Bi…

Show notes: To read more about Amgen’s Biosimilar Trends Report, click here. To learn more about the Inflation Reduction Act’s impact on biosimilars, click here. To see more of Chad’s takeaways from older version of Amgen’s Biosimilar Trends Report, click here. To learn more about tender systems, click here. To check out the last episode of Not So …

This episode is made in conjunction with the third annual Global Biosimilars Week, a biosimilar awareness campaign hosted by the International Generic and Biosimilar Association (IGBA) from November 14 through November 18. The Center for Biosimilars is a proud media partner for Global Biosimilars Week and you can check all our social media pages to…

Show notes Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable Biden Authorizes Update to the Biosimilar User Fee Act Through 2027 New Bill Aims to Remo…

Show notes: To read more of Kathy’s thoughts on the practice perspective regarding biosimilars, click here. To learn more about automatic substitution policies, click here. To learn more about some of the challenges clinicians could face next year as adalimumab biosimilars enter the market, click here. To learn more about prescription behaviors reg…

Show notes FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar https://www.centerforbiosimilars.com/view/fda-approves-stimufend-the-us-sixth-pegfilgrastim-biosimilar FDA Approves Celltrion Biosimilar for Avastin, Vegzelma https://www.centerforbiosimilars.com/view/fda-approves-celltrion-biosimilar-for-avastin-vegzelma Oncology, Ophthalmol…