Not So Different: a Podcast from The Center for Biosimilars: Recent Episodes
Not So Different: a Podcast from The Center for Biosimilars
"Not So Different," a podcast from The Center for Biosimilars, brings you expert viewpoints from physicians, pharmacists, patients, developers, and other stakeholders in the complex world of biosimilar therapies.
To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, click here.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.
ReferencesJeremias 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
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 notes1. 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 notes1. FDA Approves High-Concentration Cyltezo 2. Eye on Pharma: Simlandi US Launch; Ranibizumab Partnership; Expanded Access for Adalimumab Biosimilars 3. DDW 2024 Posters Evaluate Safety, Efficacy, Impact of BMI on Zymfentra Use 4. Posters Demonstrate Switching Safety Between Originator, Biosimilar Infliximab in IBD 5. New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching 6. Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD 7. Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings 8. Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar 9. 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 notes1. AAD Posters Examine Clinical Effects of Switching to Ustekinumab, Adalimumab Biosimilars 2. Posters From AMCCBS and AAD Showcase New Technology for Biosimilar Uptake, Barriers to Self-Injectable Biologics 3. Webinar Addresses Solutions to Improve Adalimumab Biosimilar Uptake 4. Adalimumab Expenditures in Countries With and Without Available Biosimilars 5. Review: Real-World Evidence Confirms Effectiveness and Safety of Adalimumab Biosimilar SB5 6. Study: More Biosimilar Competition Is Not Lowering Patient OOP Costs 7. 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 notes1. Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle? 2. Part 1: Oncology Biosimilars Offer Comparable Benefits to Originators at Lower Prices 3. Part 2: French Study Finds Trastuzumab Biosimilar Program Could Generate Meaningful Savings 4. Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe 5. Denosumab Biosimilar Demonstrates Positive Safety Results in Chinese Study 6. Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate 7. Similar Safety Profiles of Biosimilar, Reference Pegfilgrastim Found in Clinical Studies 8. 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 notesTo 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: 1. Biosimilars: What You Should Know 2. 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 NotesFDA 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 SavingsSamsung Bioepis Report Correlates Biosimilar Pricing Changes With Market AdoptionBiosimilars Business News Recap: A New Partnership; Celltrion Wins TendersTocilizumab Biosimilar LZM008 Demonstrates PK Equivalence in Healthy ParticipantsRWE: 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
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 regarding biosimilars, click here.
To listen to another podcast episode on a tool that can improve infusion center efficiency, click here.
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, Ophthalmology Biosimilars Progress in Europe
https://www.centerforbiosimilars.com/view/oncology-ophthalmology-biosimilars-progress-in-europe
Biosimilars Check-In: Canada Approves Third Etanercept; Prestige Withdraws Trastuzumab Application
https://www.centerforbiosimilars.com/view/biosimilars-check-in-canada-approves-third-etanercept-prestige-withdraws-trastuzumab-application
Coherus Rep Shares Competition Strategy for Adalimumab, Pegfilgrastim Biosimilars
https://www.centerforbiosimilars.com/view/coherus-rep-previews-interchangeable-ranibizumab-adalimumb-launches-on-pro-competitor?seriesVid=5
Policy Harmonization, Clarification Could Aid Biosimilar Uptake Efforts
https://www.centerforbiosimilars.com/view/policy-harmonization-clarification-could-aid-biosimilar-uptake-efforts
Upcoming WHO Guideline Changes May Reduce Data Requirements for Biosimilar Development
https://www.centerforbiosimilars.com/view/upcoming-who-guideline-changes-may-reduce-data-requirements-for-biosimilar-development
Dr Ivo Abraham Column: When More May Yield Less—Price Erosion of Biosimilars Following US Market Entry
https://www.centerforbiosimilars.com/view/dr-ivo-abraham-column-when-more-may-yield-less-price-erosion-of-biosimilars-following-us-market-entry
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 Crop of Adalimumab Options,” click here.
To read part 2 of this series, “For Patients and Employers, 2023 Means a Changed Landscape,” click here.
To read part 3 of this series, “How Adalimumab Biosimilars Will Impact Clinicians,” click here.
To listen to the other podcast in this series, “What Will Year 1 Look Like for Adalimumab Biosimilars?” click here.
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 Crop of Adalimumab Options,” click here.
To read part 2 of this series, “For Patients and Employers, 2023 Means a Changed Landscape,” click here.
To read part 3 of this series, “How Adalimumab Biosimilars Will Impact Clinicians,” click here.
To listen to the other podcast in this series, “What Will Year 1 Look Like for Adalimumab Biosimilars?” click here.
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-backward-for-biosimilar-competition
$35 Insulin Cap for Private Sector Blocked From Budget Reconciliation Bill
https://www.centerforbiosimilars.com/view/-35-insulin-cap-for-private-sector-blocked-from-budget-reconciliation-bill
European Commission Approves Second Lucentis Biosimilar
https://www.centerforbiosimilars.com/view/european-commission-approves-second-lucentis-biosimilar
FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to Ranibizumab
https://www.centerforbiosimilars.com/view/fda-approves-coherus-cimerli-as-interchangeable-biosimilar-to-ranibizumab
FDA Approves High-Concentration Formulation of Samsung Bioepis’ Humira Biosimilar
https://www.centerforbiosimilars.com/view/fda-approves-high-concentration-formulation-of-samsung-bioepis-humira-biosimilar
Eye on Pharma: Celltrion Aims for Adalimumab Interchangeability; Phase 3 Results for Ustekinumab Biosimilar
https://www.centerforbiosimilars.com/view/eye-on-pharma-celltrion-aims-for-adalimumab-interchangeability-phase-3-results-for-ustekinumab-biosimilar
EC Grants Celltrion Avastin Biosimilar Marketing Authorization
https://www.centerforbiosimilars.com/view/ec-grants-celltrion-avastin-biosimilar-marketing-authorization
BLA Accepted for Fresenius Kabi Tocilizumab Biosimilar
https://www.centerforbiosimilars.com/view/bla-accepted-for-fresenius-kabi-tocilizumab-biosimilar
Show notes:
To learn more about McKesson’s Intrafusion, click here.
To learn more about biosimilar storage concerns, click here.
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 a biosimilar
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.
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 more on the anticipation for aflibercept biosimilars, click here.
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.
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.
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 market.
We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, an associate editor for the Journal of the Advanced Practitioner in Oncology, and an assistant professor at the Mayo Clinic School of Medicine, to discuss what tactics biosimilar companies are using to better compete alongside originator manufacturers.
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 therapeutic or supportive agent. Additionally, some clinicians worry about having to stock multiple biosimilars for a single reference product. These may require different storage conditions and increase the risk of administering the wrong agent, creating financial risk for the practice. We sat down with Gary Lyman, MD, MPH, an oncologist, hematologist, public health researcher, and long-time biosimilar advocate who has also helped develop guidelines in support of using biosimilars in the oncology space. We discussed what steps are needed to improve physician confidence in using biosimilars.
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.
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.
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.
To hear more comments from Ping Cao, click here. To learn more about Henlius’ development plans, click here. To learn more about Henlius’ approval for their adalimumab biosimilar, click here. To learn more about PD-1 inhibitors, click here.
To learn more about Sonia’s work, click here.
To learn more about pharmacists’ role in promoting biosimilars, click here.
To learn more about payer preferences, click here. To see how Minnesota legislators are working to override payer preferences, click here. For more on payer influence on prescribing patterns, click here. For more on NCCN’s biosimilar work, click here. You can also check out part 1 and part 2 of this series. To check out our Biosimilar Approvals navigator, click here.
To learn more about struggles regarding physician decisions on biosimilars, click here. For more on payer influence on prescribing patterns, click here. For more on NCCN’s biosimilar work, click here.
For more on biosimilar perception, click here. For more on NCCN’s biosimilar work, click here.
To learn more about the bill, click here. To read the bill’s official text, click here. To learn more about payer formulary preferences, click here.
To learn more about Valenti and Cerwicki's updated guide, click here. To learn more about adalimumab patent disputes, click here. To learn more about the future state for the adalimumab market, click here. To take our quiz on adalimumab, click here.
To learn more about phase 3 of the BC Biosimilars Initiative, click here. To learn more about recent biosimilar launches in Canada, click here or here. To learn more about biosimilar switches in Canada, click here. To learn more about other Canadian province’s biosimilar plans, click here. To learn more about Pacific Blue Cross’s success with the program, click here.
To learn more about Celltrion's EU approval, click here. To learn more about Alvotech’s high concentration adalimumab, click here. To learn more about high-concentration citrate-free adalimumab products, click here. To learn about the patent dance, click here. For more in adalimumab news, click here or here.
To learn more about BI’s citizen petition, click here. To hear more from Steven Lucio, PharmD, BCPS, click here. To learn more about Vizient, click here.
You can read more about China’s market by clicking here or here. For information on Bio-Thera, click here. For information on Shanghai Henlius Biotech, click here.
To watch the full first part of this interview, click here. To watch part 2 of this interview, click here. To watch part 3 of this interview, click here.
To learn more about biosimilar barriers, click here. To learn more about the US Oncology Network, click here. To learn more about McKesson, click here.
To learn more about the COA's virtual Payer Exchange Summit on Oncology Payment Reform, click here.
To learn more about Pontchartrain Cancer Center, click here.
To learn more about the study mentioned in this podcast, click here. To learn more about the United Kingdom's stance on comparative efficacy trials, click here.
To learn more about the ACR’s survey, click here. To learn more about COVID-19’s impact on biosimilars, check out our ebook here.
To read more on Wayne’s thoughts of this plan, click here. To learn more about the Safe Importation Action Plan, click here. To learn more about President Trump’s executive orders, click here.
To learn more about COVID-19's impact on biosimilars, click here.
To learn more about biosimilar education, click here.
To learn more about step therapy, click here.
To learn more about payer interference on preferred drugs, click here.
To learn more about HR 8190, click here.
To learn more about the regulatory transition of insulin under the BPCIA, click here.
To learn more about interchangeability designations, click here.
To check out more of our coverage of Polpharma Biologics, click here.
To learn more about Polpharma's natalizumab clinical trial, click here.
To learn about Polpharma Biologics recent integration efforts, click here.
To learn more about Polpharma Biologics, click here.
To learn more about MBGH's call to action for employers, click here.
To learn more about MBGH's biosimilars report, click here.
To learn more about Midwest Business Group on Health, click here.
To learn more about the EC's approval of Aybintio, click here.
To learn more about Samsung Bioepis, click here.
To learn more about biosimilar naming, click here.
Click here to learn more about the ACMA.
To check out the scorecard, click here.
To learn more about Medicines for Europe, click here.
To learn more about the opinion piece McCabe co-authored, click here.
To learn more about Boehringer Ingelheim, visit boehringer-ingelheim.com.
To learn more about Celltrion Healthcare, visit celltrionhealthcare.com.
You can learn more about the testing of Celltrion's infliximab biosimilar for the treatment of COVID-19 here.
The United States’ slow start to biosimilar uptake has manifested in a number of ways, from delayed launches due to patent disputes to anticompetitive practices creating a distrust of biosimilars among patients and physicians. However, some experts still see hope for the industry.
We sat down with Joe Fuhr, PhD, professor emeritus of economics at Widener University in Chester, Pennsylvania, and an expert on antitrust health economics and pharmacoeconomics to discuss the current state of the biosimilar landscape and what he sees going forward.
To learn more about the approval of Nyvepria, check out our article on it here.
To learn more about Goodwin Proctor LLP, visit goodwinlaw.com/
To learn more about Venable Fitzpatrick, visit venable.com.
To learn more about all of the bills that were discussed, visit congress.gov
It’s no secret that the US biosimilar industry has had a slow start in terms of uptake, but much of that setback is due to barriers caused by originator manufacturers taking advantage of current legislation. Although, the Hatch-Waxman Act and the Biologic Price Competition and Innovation Act (BPCIA) established pathways to approval for both generic drugs and biosimilars, there is still much legislative work to be done in order to truly reap the benefits of biosimilars. We sat down with April Breyer Menon, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago, Illinois, to discuss potential legislation such as The Hatch-Waxman Integrity Act and the Stop Stalling Act that would address barriers to biosimilar market entry.
In April 2020, Samsung Bioepis launched Ontruzant, a biosimilar for trastuzumab, in the US market, in partnership with Merck. The company launched the same drug in Europe in 2018, and it was the first trastuzumab biosimilar in Europe. This earlier release of biosimilars in Europe is not an anomaly, as Europe has had a much easier time developing and launching biosimilars than the US thanks to their decade-long head start in the industry. We sat down with Dr. Sang-Jin Pak, the executive vice president of Samsung Bioepis’ Commercial Division to discuss the differences between the US and Europe.
On March 23rd, 2020, the transition under the Biologics Price Competition and Innovation Act was complete, allowing products formerly classified as “small-molecule” drugs, including all insulin products, to be approved under the biologics regulatory pathway. This week on the podcast, we’re speaking with executive director of the Biologics and biosimilars collective intelligence consortium (also known as the BBCIC) , Cate Lockhart, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how this new transition will impact the market and uptake efforts.
With pharmaceutical spending at record levels, employers are looking for solutions and are hopeful that biosimilars can play a role in controlling costs. On this episode, we speak with representatives of EmployersRX, a new coalition made up of 3 employer groups that are advocating for measures that would provide relief for the largest purchasers of healthcare.
In the past decade of experience with the the Biologics Price Competition and Innovation Act, a number of questions about the biosimilar pathway have been resolved through litigation. This week on the podcast, we're speaking with attorneys Robert Cerwinski, JD, and Alexandra Valenti, JD, both of whom are partners at Goodwin, about experience with litigation, the road ahead for biosimilars, and Goodwin's recently published guide to biosimilar litigation.
When it comes to US biosimilars, 2019 was a busy year for regulatory activity. This week on the podcast, we're rounding up the key developments of the year.
During the American College of Rheumatology’s recent 2019 annual meeting, we caught up with Paul Emery MD, FRCP, MA, FMedSci. Emery is the Versus Arthritis Professor of Rheumatology, University of Leeds, and the Director of the Leeds Musculoskeletal Biomedical Research Centre at Leeds Teaching Hospitals Trust in the United Kingdom. In this episode of the podcast, we’re sharing highlights of our interview with Emery about biosimilars.
With us on the podcast to talk about recent and upcoming biosimilar launches is Sean McGowan, senior director of biosimilars at AmerisourceBergen. McGowen spoke with us about what the US biosimilars market needs now in order to thrive, and tells us which developments he'll be watching closely in 2020.
Last month, the European Commission authorized a subcutaneously administered formulation of biosimilar infliximab CT-P13 for the treatment of rheumatoid arthritis. When the drug launches in the European Union, it will be first infliximab to be available in a subcutaneous formulation. This week on the podcast, we’re speaking about this new product with Mike An, head of the sales and operations division at Celltrion Healthcare.
This week on the podcast, we’re rounding up the top biosimilar business stories of November 2019.
As fee-for-service models give way to value-based healthcare delivery models, US providers and patients alike can hopefully forward to lower healthcare costs, increased quality of care, and improved outcomes. But what role will biosimilars have to play in value-based care?
This week on the podcast, we're speaking with Jeffrey Scott MD, chief medical officer of Integra Connect, a company that uses cloud-based technologies and services that help specialty care providers optimize their performance in the ongoing shift to value-based models. Scott spoke with us about value-based contracting in the biosimilars context.
In October of this year, the nonprofit organization HealthyWomen, a group that seeks to educate women to make informed choices about their health, hosted its first Biosimilars and Women’s Health Science and Policy Forum. This week on the podcast, we’re speaking with one of the presenters from that meeting, Lisa Kennedy Sheldon, PhD, APRN, AOCNP, FAAN.
Back in September, AARP, issued its latest Rx Price Watch report, which highlighted the problem of skyrocketing drug costs; it found the retail prices for widely used drugs increased well above the rate of inflation, and that’s a troubling trend for Medicare beneficiaries. This week on the podcast, we’re speaking with one of the authors of that report, Leigh Purvis, MPA, who says that the problem of high costs will eventually impact all Americans.
With new research being presented, and with new biosimilars in the pipeline that target inflammatory bowel disease, October was a notable month for biosimilars in the gastroenterology space. This week on the podcast, we’re rounding up the top developments in gastroenterology for the month of October 2019.
In August of this year, the US District Court for the District of New Jersey ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi. As a result of that decision, biosimilar etanercept appears to be on a lengthy hold in the US market, and that has a number of biosimilar stakeholders concerned.
This week on the podcast, we’re speaking with Rick Lozano, vice president of Biosimilars and Integrated Business Development for AmerisourceBergen. We discuss the ruling in the case, its potential impacts on the healthcare system, and what drug makers can do now to help educate other stakeholders about biosimilars and improve uptake.
It’s widely expected that the United States will see launches of one or both of the FDA-approved biosimilars, Ruxience and Truxima, in the coming months, but just how ready is the United States to bring these products to the clinic, especially given the fact that subcutaneously administered reference rituximab has taken on such a key place in clinical practice, and given the fact that both biosimilars have so-called “skinny labels” because of issues related to intellectual property and exclusivities?
Over the past year, we’ve had the opportunity to explore these questions and more with a variety of experts in the oncology field. This time on the podcast, we’re rounding up some of the key insights they’ve shared.
Among the biggest biosimilars news of this year was the launch of the first 2 anticancer biosimilars; stakeholders have been eager to see whether these products can jumpstart what has been described by some as a sluggish US market for biosimilar products. This week on the podcast, we're speaking with an expert who's sharing her insight into these developments in the oncology space.
Christina Corridon, MPH, MBA, is a principal at the professional services firm ZS Associates, where she is a leader in ZS' oncology practice and leads their biosimilars vertical. Christina joined us to talk about the state of play in the US biosimilars market, what we can learn from ongoing experience, and how sustainable the US market for biosimilars may be today.
The question of whether anticancer biosimilars will achieve strong uptake in the United States, and whether they will produce much-needed cost savings, is one that has pervaded the conversation about US biosimilars for some time. Shortly after Amgen launched the first 2 such agents, biosimilar trastuzumab and bevacizumab, OneOncology, a group that comprises 4 large community oncology practices and 100 sites of care, announced that it had made those 2 biosimilars preferred agents.
This week on the podcast, we’re speaking with Jeffrey Patton, MD, chief executive officer of Tennessee Oncology, a partner practice of OneOncology, and the President of Physician Services for OneOncology. Patton shares with us the rationale for the adoption of biosimilars, how patients are responding, and lessons learned.
In its semiannual drug pricing forecast, healthcare performance company Vizient said that biosimilars will be a key part of combatting rising spending on drugs. This week on the podcast, we're speaking with Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient, on how oncology biosimilars are poised to make an impact.
It's no secret that biosimilars that treat inflammatory diseases have struggled to gain ground in the United States, but given the benefits that biosimilars can offer, some physicians are taking matters into their own hands with concerted efforts to bring biosimilars to the clinic. This week on the podcast, we're speaking with Colin C. Edgerton, MD. He's one of the founding members of Articularis Health Group, which has created a value-based rheumatoid arthritis treatment pathway that has boosted biosimilar use.
In July, the Trump administration withdrew its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations. HHS previously said that the rule would counteract incentives behind higher list prices.
Withdrawal of the rule was a discouraging development for many physicians who hoped that the proposal could give relief to their patients at the pharmacy counter. This week on the podcast, we’re speaking to one such physician, Madelaine Feldman, MD.
The Biosimilars Council, a part of the Association for Accessible Medicines, recently issued a white paper in which it condemns abuses of the patent system that delay biosimilar competition. The group estimates that the financial impact of these delays has cost the US healthcare system $7.5 billion in lost savings since 2015. This week on the podcast, we’re speaking with Christine Simmon, executive director of the Biosimilars Council, about the paper, about patent thickets, and about what policy issues the organization wants to see addressed to move the needle on biosimilars.
At the beginning of this year, we spoke with Laura Joszt, associate editorial director and the host of The American Journal of Managed Care’s podcast, Managed Care Cast, about where biosimilars stood at the end of 2018. Now, halfway through the year, we’re continuing that conversation with a look at how biosimilars have fared so far in 2019.
Industry group the Biosimilars Forum recently put forth 3 policy proposals that it says could save the US healthcare system billions of dollars. This week on the podcast, we’ve invited the forum to tell us more about their proposals and other policy issues related to biosimilars. Joining us this week are Juliana Reed and Molly Burich. Reed is the vice president corporate affairs, global biosimilars lead at Pfizer, and is also president of the forum. Burich is director of public policy, biosimilars, and reimbursement at Boehringer Ingelheim, and an officer in the forum.
While pay-for-delay issues have been big news on Capitol Hill recently, some experts have questions about whether these kinds of settlements are really at the heart of delayed biosimilar competition, and they offer alternative ways to think about—and to fix—the problem. This week on the podcast, we’re speaking with 2 such experts, Imron Aly, JD, and Joel Wallace, JD. Both are partners at Schiff Hardin LLP and have extensive experience with Hatch-Waxman and biosimilars intellectual property issues.
Recently, the FDA released its long-anticipated final guidance on demonstrating interchangeability, and developers have been grappling with how the guidance will impact them. This week on the podcast, we're speaking with regulatory attorney James Shehan, JD, chair of regulatory practice at Lowenstein Sandler, LLP. In a prior role, Shehan had a hand in crafting the language that became the Biologics Price Competition and Innovation Act, which set forth the legal standard for interchangeability. Shehan discusses what the newly released guidance means for developers, what he thinks about the upcoming transition of insulins to regulation as biologics, and his view on the potential for interchangeable insulin biosimilars.
Amid growing concern about the skyrocketing cost of insulin in the United States, the FDA held a public hearing this month about biosimilar insulins. This week on the podcast, we caught up with one of the experts who testified at the hearing: Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient. He shared his thoughts with us on biosimilar insulins, interchangeability, biosimilar suffixes, and what milestones lie ahead as the United States approaches its 2020 transition of insulins to regulation as biologics.
The cost of cancer care is on the rise worldwide, and biosimilars present one option for bringing down costs. However, those savings depend on adoption and use of biosimilars, and hesitancy to use these agents on the part of prescribers has been well documented. One newly published study reported on a survey conducted among European Society for Medical Oncology (ESMO) members and attendees of the 2017 ESMO Congress in Madrid, Spain, concerning biosimilars.
This week, we’re speaking with the study’s lead author, Rosa Giuliani, MD. She’s a medical oncologist at The Christie Hospital, Manchester, United Kingdom, and Chair of the ESMO Global Policy Committee.
In a 2-part proposal published on the Health Affairs blog, a team of authors argued that efforts to induce lower prices through competition via biosimilars will inevitably fail. Instead, they write, prices for innovator biologics should be regulated by the US government after patent expiry.This week on the podcast, we’re talking with Mark Trusheim, MS, one of the authors of the proposal.
Recent months have seen a variety of proposals to bring down the cost of prescription drugs, but will any of them have staying power? This week, senior editor Allison Inserro speaks with Robin Feldman, professor at the University of California, Hastings, College of the Law, and author of the new book Drugs, Money, and Secret Handshakes: The Unstoppable Growth of Prescription Drug Prices.
The recent weeks and months have seen a number of policy proposals from the Trump administration that impact community oncologists. On this week's podcast, Laura Joszt, associate editorial director of The Center for Biosimilars®, caught up with Ted Okon, MBA, executive director of the Community Oncology Alliance.
Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address misinformation. This time on the podcast, we’re sharing a portion of that discussion with our listeners.
This week on the podcast, we're speaking with Civica Rx’s Heather Wall. She’s the organization’s chief commercial officer, and was recently named one of Modern Heatlhcare’s women leaders to watch.
Those who follow the biosimilars space closely are aware that, in the context of the US market, legal concerns regarding biosimilars can be just as regulatory ones in informing how drug makers do business.
One recent case that impacts on upon the biosimilars market was recently heard before the before the United States Supreme Court, and the outcome of the case will potentially impact drug makers seek patent protection for various aspects of their products.
In order to take a deeper dive into the case, and hear an expert perspective on its far-reaching impacts, this week, we’re speaking with Ha Kung Wong, JD, a partner at Venable LLP and an advisory board member for The Center for Biosimilars.®
Recently, a new systematic review evaluating US and European provider awareness of biosimilars found a persistent lack of education on both sides of the Atlantic. This week, The Center for Biosimilars® is speaking with Sonia T. Oskouei, PharmD, one of the authors of the review, about the findings.
2018 was a banner year for biosimilars, both in the United States and abroad. In this episode of the podcast, Laura Joszt, associate editorial director of The American Journal of Managed Care, interviews The Center for Biosimilars’ senior editor, Kelly Davio, about the key developments in biosimilars last year.
This season on the podcast, we’re bringing you the news you need to stay up to date on the key issues facing biosimilars. In this episode, we’ll talk about what’s new in biosimilar regulation.
Recently, Louis Tharp, the cofounder and executive director of the patient advocacy organization the Global Healthy Living Foundation, visited our studios in New Jersey to talk about how high drug costs impact patients with rheumatic diseases, and how biosimilars can be part of the solution. What follows is a portion of our discussion about biologics, biosimilars, and the patient's viewpoint.
Among the great promises of biosimilar therapies is their ability to not only reduce costs for patients and healthcare systems, but to make room in budgets for spending on other high-cost drugs, especially in treating cancer.
This week on “Not So Different,” our guest is Ali McBride, PharmD, MS, BCPS. McBride is pharmacist who serves as the Clinical Coordinator for Hematology and Oncology at The University of Arizona Cancer Center. He’s also the lead author of a recent study that showed that using biosimilar filgrastim can expand patients’ access to treatment with obinutuzumab.
This week on the podcast, we’re pleased to welcome our guest, Leigh Purvis, MPA. Purvis is the director of health services research at AARP’s public policy institute. Her work focuses on a variety of prescription drug and mental health-related issue, with an emphasis on prescription drug pricing, biologic drugs, and prescription drug coverage under Medicare.
Purvis joined us by phone to talk about the challenges that Medicare beneficiaries face with respect to obtaining and paying for their biologic drugs, and about the policies that AARP hopes to see implemented in the days ahead.
This week, we're delving into the world of supportive care and anticancer biosimilars with an oncology expert, Robert M. Rifkin, MD, FACP.
Today, we're talking about state-level legislation concerning the substitution of interchangeable biosimilars, and how 1 specific piece of biosimilars-focused legislation led to the formation of the Nebraska Rheumatology Society. Our guest this week is Marcus Snow, MD, a rheumatologist at the University of Nebraska Medical Center, and assistant professor of rheumatology at the University of Nebraska.