Not So Different: A Podcast From The Center For Biosimilars

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

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 Competition Report: Varied Biosimilar Uptake Speeds Pose Missed Opportunities for Cost Savings Biosimilar SB5 Matches Originator in Safety, Efficacy for Inflammatory Diseases After Switching Postapproval Pharmacovigilance Review Confirms Comparable Safety Between Sandoz Biosimilars, Originators

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 episodes featuring more of Brian's insight into how the adalimumab market will develop and biosimilar pricing trends, click here or 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. 

 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 Europe Denosumab Biosimilar Demonstrates Positive Safety Results in Chinese Study Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate Similar Safety Profiles of Biosimilar, Reference Pegfilgrastim Found in Clinical Studies Study: Biosimilar Use, Dose Rounding Produce More Cost Savings Than Either Strategy Alone

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.

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; Cimerli’s Growing Market Share; BBCIC Awarded Grant Samsung Bioepis Presents Positive Phase 3 Data on Aflibercept Candidate AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry

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 Forward Alvotech’s Stelara Biosimilar Approved in Japan EC Approves First MS Biosimilar; Coherus Receives CRL for Neulasta Onpro Competitor European Commission Approves First Aflibercept Biosimilar Regulatory Updates From Around the Globe Provide Hope for Biosimilars

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 Hyrimoz, Hadlima, Yusimry, and Cyltezo Click here for the launch of Yuflyma Click here for the launches of Idacio and Hulio

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 Health Exec: How Adalimumab Biosimilars Can Reshape the US Health Care Industry

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.

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 Steep Discounts, Humira Biosimilars Are Priced More Than Original Originator Price Price Reductions of TNF Inhibitors Across Europe After First and Second Biosimilar Launches Multiple Infliximab Biosimilar Switches Were Safe, Effective Adalimumab Biosimilar Improved Symptoms for up to 48 Weeks in Ankylosing Spondylitis Biosimilar, Innovator Romiplostim Comparably Safe and Effective

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 Video 

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 Stakeholders Can Prepare Alvotech, Advanz Pharma Extend Partnership for Biosimilars in Europe Medicare 340B Program May Be Reducing Biosimilar Uptake Sandoz Roadmap Aims to Increase Worldwide Biosimilar Adoption by 2030

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 Biosimilars and the Promise of Future Savings   Samsung Bioepis Report Correlates Biosimilar Pricing Changes With Market Adoption Biosimilars Business News Recap: A New Partnership; Celltrion Wins Tenders Tocilizumab Biosimilar LZM008 Demonstrates PK Equivalence in Healthy Participants RWE: Rituximab Biosimilar GP2013 Effective in Patients With RA After Switching From Originator

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.

Show notes To read all the articles within the supplement, click here. To read the article references in this episode, click here.

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, Provider Comfort With Adalimumab Biosimilars Is Low Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars Study Reveals Factors That Dissuade Commercial Plans From Covering Biosimilars

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, click here. To learn more about ustekinumab biosimilars, click here.