Not So Different: a Podcast from The Center for 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

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 about the settlements that have resulted in the market delay of ustekinumab biosimilars, click here. To learn more about lawsuits involving AbbVie that led to the delayed market entrance of adalimumab biosimilars, click here. To learn more about what types of patents are at most to blame for biosimilar market delays, click here.

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.

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 Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 2 The Increasing Access to Biosimilars Act of 2023 Introduced to Congress Published Data Coupled With Real-world Evidence Show Safety of Biosimilar-to-Biosimilar Switching Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns

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.

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/view/report-over-60-of-providers-plan-to-only-prescribe-interchangeable-adalimumab-biosimilars IQVIA: US Spending on Biosimilars to Reach $129 Billion Over Next 5 Years https://www.centerforbiosimilars.com/view/iqvia-us-spending-on-biosimilars-to-reach-129-billion-over-next-5-years Vizient Report Predicts Over 3% Inflation Rate for Biologics https://www.centerforbiosimilars.com/view/vizient-report-predicts-over-3-inflation-rate-for-biologics On the Come Up: What Vizient's Report Says About Inflation and Biosimilars https://www.centerforbiosimilars.com/view/on-the-come-up-what-vizient-s-report-says-about-inflation-and-biosimilars Patients With RA, IBD Trust Specialists' Biologic and Biosimilar Recommendations https://www.centerforbiosimilars.com/view/patients-with-ra-ibd-trust-specialists-biologic-and-biosimilar-recommendations Study: Higher Adherence Rates Among Users of the Remicade vs Infliximab Biosimilars https://www.centerforbiosimilars.com/view/study-higher-adherence-rates-among-users-of-the-remicade-vs-infliximab-biosimilars 

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 Managed Care®, click here.

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 https://www.centerforbiosimilars.com/view/celltrion-submits-bla-for-infliximab-biobetter  FDA Accepts BLA for Alvotech Ustekinumab Biosimilar https://www.centerforbiosimilars.com/view/fda-accepts-bla-for-alvotech-ustekinumab-biosimilar  Biosimilars Check-in: Approval in Saudi Arabia, Launch in Republic of Korea, Dr. Reddy's Completes Study https://www.centerforbiosimilars.com/view/biosimilars-check-in-approval-in-saudi-arabia-launch-in-republic-of-korea-dr-reddy-s-completes-study  China's NMPA Approves Tocilizumab Biosimilar https://www.centerforbiosimilars.com/view/china-s-nmpa-approves-tocilizumab-biosimilar   US Welcomes First Adalimumab Biosimilar, Amjevita https://www.centerforbiosimilars.com/view/us-welcomes-first-adalimumab-biosimilar-amjevita  Study: Does Adalimumab Lose Effectiveness After Switching to a Biosimilar? https://www.centerforbiosimilars.com/view/study-does-adalimumab-lose-effectiveness-after-switching-to-a-biosimilar-  Phase 1 Trial for Alvotech Golimumab Biosimilar Begins https://www.centerforbiosimilars.com/view/phase-1-trial-for-alvotech-golimumab-biosimilar-begins Case Study: Treatment With Adalimumab Biosimilar Resolved Pediatric Scalp, Nail Psoriasis https://www.centerforbiosimilars.com/view/case-study-treatment-with-adalimumab-biosimilar-resolved-pediatric-scalp-nail-psoriasis 

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 learn more about ophthalmology biosimilars, click here. To learn more about interchangeability, click here. To learn more about clinical efficacy testing, click here. To learn more about our LinkedIn Live event on ophthalmology biosimilars, you can read more here or watch the full discussion here. To check out the FDA's overview page on biosimilars, click here. To check out the FDA's patient-focused biosimilar education materials (English and Spanish versions), click here. To check out the FDA's biosimilar education materials for health care professionals, click here. For more information on the FDA's biosimilar curriculum, click here. For more information on the FDA's free CE courses on biosimilars, click here and use the filter function to select biosimilars.

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: Biosimilar Competition in Europe 5. Part 1: Biosimilars to Bring a Bumper Crop of Adalimumab Options             - For the whole series, click here.  4. FDA Accepts BLAs Supporting Interchangeability From Alvotech, Pfizer for Biosimilars to Humira 3. Samsung Bioepis and Organon Seek to Enter the Market for High-Concentration Adalimumab 2. FDA Approves High-Concentration Formulation of Samsung Bioepis' Humira Biosimilar 1. Teva Announces US Launch of Lenalidomide, Generic of Revlimid Top 5 podcast episodes of the year: 5. How Health Policy Can Impact Adoption for Adalimumab Biosimilars 4. New Biosim on the Block: Dr Sonia Oskouei Discusses the US Launch of Byooviz, the First Ophthalmology Biosimilar 3. What Amgen's Biosimilar Trends Report Says About the Future of Biosimilars 2. How Health Policies May Take Shape in a Post-Humira-Exclusive Adalimumab Market 1. What Will Year 1 Look Like for Adalimumab Biosimilars?

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 Biosimilars; World's First Denosumab Biosimilar; Organon Launches in Canada Senator Introduces Bill to Rid Switching Study Requirements for Interchangeability BioRationality: A Dr Sarfaraz Niazi Column—FDA Launches Biosimilar Regulatory Science Program AAM's Craig Burton: Is the Biden Administration Doing Enough to Help Biosimilars?

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 Different, click here.

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 view our coverage of the event. To learn more about Global Biosimilars Week, click here. To learn more about BsUFA III, click here. To learn more about the Inflation Reduction Act, click here. To learn more about President Biden's executive order, click here. To learn more about President Biden's support for biotechnology, click here. To learn more about efforts to investigate pharmacy benefit managers, click here. To learn more about the FDA's recent workshop, click here. To learn more about the FDA's updated guidance on interchangeability, click here. To learn more about the approval of Cimerli, click here, and to learn more about the controversy surrounding it, click here.

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 Remove Barriers to Interchangeable Biosimilars Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years It'll Take a Village: Collaborative Efforts Needed to Increase Ophthalmology Biosimilar Uptake Order of Operations: Managing Biosimilars While Maintaining Operational Efficiency Dr Ryan Haumschild: What Health Systems Can Learn From Emory Healthcare's Biosimilar Strategy