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.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.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.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 VideoNot 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.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.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.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…

This special episode is part of a larger series called “WHEN CHOICE ARRIVES: Competition & Consequences,” consisting of 4 articles and 2 podcasts. The series delves into everything that stakeholders need to know as everyone prepares for the 2023 introduction of adalimumab biosimilars. To read part 1 of this series, “Biosimilars to Bring a Bumper Cr…

This special episode is part of a larger series called “WHEN CHOICE ARRIVES: Competition & Consequences,” consisting of 4 articles and 2 podcasts. The series delves into everything that stakeholders need to know as everyone prepares for the 2023 introduction of adalimumab biosimilars. To read part 1 of this series, “Biosimilars to Bring a Bumper Cr…

Opinion: Impact of Inflation Reduction Act 2022—Addressing Critics https://www.centerforbiosimilars.com/view/opinion-impact-of-inflation-reduction-act-2022-addressing-critics Opinion: The Inflation Reduction Act is a Step Backward for Biosimilar Competition https://www.centerforbiosimilars.com/view/opinion-the-inflation-reduction-act-is-a-step-back…

Show notes: To learn more about McKesson’s Intrafusion, click here. To learn more about biosimilar storage concerns, click here.Not So Different: a Podcast from The Center for Biosimilars

Show notes Written version of the roundup Phase 3 denosumab trial results Alvotech’s pharmacokinetics trial for denosumab Poster from the American Society of Clinical Oncology’s annual meeting Phase 1 pertuzumab trial Rituximab studies from the European Hematology Association Congress 2022 Survey on preparing patients and providers for switching to…

To learn more about the hype regarding adalimumab biosimilars in the US, click here. To see which biosimilars have been approved by the FDA, click here. To read more on PBMs and their influence on biosimilar uptake, click here. To read Manolis’ 2016 paper, click here.Not So Different: a Podcast from The Center for Biosimilars

Show notes: To learn more about the US launch of Byooviz, click here. To read more about the anticipation for ophthalmology biosimilars, click here. To read more of Dr. Oskouei’s comments on “Round 2,” click here. To learn more about the EU approval of Byooviz, click here. To learn more about the Canadian approval of Byooviz, click here. To read mo…

To listen to part 1 of this podcast, click here. To listen to part 2 of this podcast, click here. To learn more about building patient confidence in biosimilars, click here. To learn more about how education can improve patient confidence, click here.Not So Different: a Podcast from The Center for Biosimilars

To listen to part 1 of this podcast, click here. To learn more about building physician confidence in biosimilars, click here. For more on how switching to biosimilars can impact budgets and savings, click here.Not So Different: a Podcast from The Center for Biosimilars

Despite some biosimilars, including those for filgrastim, trastuzumab, and bevacizumab, achieving a greater US market share than their originators, other biosimilar categories, such as pegfilgrastim and infliximab, are still trailing behind. Some biosimilar companies are becoming more savvy, developing new ways to make a bigger statement in the mar…

A major barrier to biosimilar adoption is physician hesitancy when it comes to prescribing these agents, especially in the oncology space. Physicians often want more clinical or real-world evidence on the safety and efficacy of biosimilars compared with reference products in patients with cancer, for whom the stakes are high when choosing a therape…

To hear more from Paul on biosimilar issues, click here or here. To read about Paul’s insight on the current issues in the Indian biosimilar market, click here.Not So Different: a Podcast from The Center for Biosimilars

To learn more about the Hatch-Waxman Act, click here. To learn more about how biosimilars compare with the generics market, click here. To learn more about the challenges that both the biosimilars and generic markets face, click here.Not So Different: a Podcast from The Center for Biosimilars

For background reading on the ACA case, read about the June 2021 ruling here, and for background on the withdrawal of the Department of Justice from the plaintiffs’ side of the suit, click here.Not So Different: a Podcast from The Center for Biosimilars