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BIOSIMILAR APPROVALS

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Articles

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

A new study confirms KM118, a proposed biosimilar to pertuzumab, shows pharmacokinetic similarity and safety, paving the way for affordable HER2-positive breast cancer treatments.

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

The US biosimilar market evolves with 90 approvals, significant price drops, and new PBM models enhancing access to cost-effective therapies.

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

Alex Keeton serves as the executive director of the Biosimilars Council.

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

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Business & Practice

Biosimilars Council Wants Elimination of 6-Month Exclusivity for Biologics 

How Will the Genentech-Amgen Feud Bear Down on Biosimilar Development?

FDA Accepts Mylan-Biocon Pegfilgrastim Biosimilar Application

AbbVie, Novartis Unhappy With FDA Guidance on Naming Biologics and Biosimilars

 Legal and Regulatory Decisions Likely to Drive Biosimilar Approvals in 2017

FDA Filing of Sandoz's Humira Biosimilar Delayed 

All things biosimilars

In the special video podcast episode, produced in partnership with the Association for Accessible Medicines (AAM), co-hosts Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at AAM, and Alex Keeton, the new executive director of AAM's Biosimilars Council, break down one of the most consequential policy shifts in the biosimilar landscape in years: the FDA’s new draft guidance on comparative efficacy studies (CES) and interchangeability. 

Keeton opened the discussion by outlining how the agency’s updated scientific framework aims to streamline biosimilar development by reducing, and in many cases eliminating, the need for large, costly comparative efficacy studies. Instead, the FDA is formally recognizing that advanced analytical tools and pharmacokinetic data are often more sensitive and scientifically meaningful than clinical efficacy trials—an evolution that could save manufacturers years of development time and as much as $100 million to $300 million per program.

Randazzo emphasized the potential impact on access, noting that lower development costs can help expand competition and deliver more affordable biologic alternatives to patients. The hosts highlighted growing political momentum behind biosimilars following a recent press conference in which federal officials framed the guidance as a shift from bureaucracy to science. However, they also pointed to persistent policy gaps, including state-level substitution restrictions and the continued statutory existence of the interchangeable designation—an issue the hosts argued now requires Congressional action to align the law with current FDA science.

The conversation also addressed the “biosimilar void,” a term describing more than 100 biologics that are approaching patent expiration with no biosimilars in active development. Randazzo noted that reducing clinical trial requirements alone will not close this gap; challenges such as manufacturing complexity, market incentives, and payer-side barriers continue to slow progress.

Keeton and Randazzo closed by previewing a future episode dedicated entirely to payer dynamics, reinforcing that regulatory reform is only one piece of the broader effort to make biosimilars more accessible and sustainable across the US health care system.

To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, 

To read more about G's discussion with Sarah Yim, MD, from the FDA from the recent 2025 GRx+Biosims conference, 

To read more on Yim's perspectives on biosimilar policy harmonization, 

In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market

Escaping the Void: All Things Biosimilars With Craig & G

Co-hosts Craig Burton, executive director of the Biosimilars Council, and Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

This special vodcast series provided by The Center for Biosimilars

 was developed in partnership with the AAM and Biosimilars Council.

By Ashley Henyan, MA, MFA, director of communications at AAM

Since the passing of the Biologics Price Competition and Innovation Act in 2010, the FDA has approved over 70 biosimilar medicines. Since their entry to market in 2015, biosimilars have generated $36 billion in savings for America's patients and the US health care system. Biosimilars have proven they can unlock access to safe, effective, and more affordable treatments. But unfortunately, a dangerous trend threatens to halt progress related to biosimilar uptake and patient access. 

In February 2025, an analysis from the IQVIA Institute revealed a massive biosimilar void.

 A staggering 90% of biologic drugs losing patent exclusivity over the next 10 years have no biosimilar competition in the pipeline. This data underscores a flawed system that limits patient access and negatively impacts the livelihood of millions of Americans. 

However, when it comes to biosimilars, we have the tools to fix the problem. With the right focus, collaboration, and reforms, we can ensure biosimilars continue to bring value to patients, providers, and the broader health care system. 

With thanks to The Center for Biosimilars, this podcast series explores the current biosimilars landscape, dives into urgent actions needed from policymakers and regulators, and offers real-world insights into what changes are needed now to ensure the sustainability of the industry. 

1. 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

To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

This episode of Not So Different explores the possible implications of the Federal Trade Commission's (FTC) second interim report on pharmacy benefit managers (PBMs), which shed light on key issues with current PBM practices and their impact on drug prices. The report highlighted several troubling strategies, such as many cases where the big 3 PBMs were reimbursing their own affiliated pharmacies at higher rates than independent pharmacies. The report's latest findings raise important questions about the future of drug pricing transparency and regulation and challenge the notion of whether PBMs are delivering on their intended promise to benefit the health care system.

To help unpack these findings and their implications, The Center for Biosimilars

 was joined by Joe Wisniewski, an expert in PBM legislation, price transparency, and health care policy. Joe serves as assistant vice president of partnerships and government affairs at Turquoise Health and brings a wealth of insight into how PBMs are navigating the current landscape, especially with the rise of new biosimilars and shifting regulatory pressures.

This episode also explores how a second Trump administration could influence PBM practices, particularly in relation to biosimilars, and what that means for drug pricing efforts moving forward.

To learn more about the FTC's most recent report on PBMs, 

To learn more about the FTC's first report on PBMs, 

To learn more about health care actions taken by the second Trump Administration during it's first month, 

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, 

On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.

Will the FTC Be More PBM-Friendly Under a Second Trump Administration?

As 2023 comes to a close, we look back on some of the major advancements from the past year, from the long-awaited market introduction of adalimumab biosimilars in the US, to the first major regulatory approvals for neurology biosimilars, to the implementation of key policy initiatives around the globe.

A lot of eyes have been on the United States and 2024 shapes up to be another big year for the biosimilar industry, with approvals for denosumab, aflibercept, and on-body pegfilgrastim biosimilars on the way. Additionally, the nation will continue to see the fallout from the implementation of the Inflation Reduction Act (IRA), including its policies regarding Medicare price negotiations, as well as the role interchangeability designations will play into adoption rates. It also remains to be seen whether payers and pharmacy benefit managers (PBMs) are ready to embrace newer biosimilars and add them to formularies as preferred products, leaving the future for a sustainable biosimilar industry up in the air.

Today, I'm joined by Brian Biehn, senior director of biosimilar commercialization, and Corey Ford, vice president of reimbursement and patient access, and policy insights at Cencora (formerly AmerisourceBergen). Both of them have been keeping a close watch on the biosimilar space throughout the year and today's discussion will surround how this year sets up a new chapter for the industry.

To learn more about the prospect for Neulasta OnPro biosimilars, 

To learn more about how the IRA will impact biosimilars, 

To learn more about the dual-pricing strategy being used for adalimumab biosimilars, 

To hear Brian's insight into how the ophthalmology biosimilar industry is developing, 

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, 

On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.

A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond

In late October 2023, the FDA approved Zymfentra (infliximab-dyyb), the world's first subcutaneous infliximab product. The product's development was based on Inflectra (infliximab-dyyb), an intravenous infliximab biosimilar referencing Remicade (infliximab). However, because the reference product does not have a subcutaneous option, Zymfentra was approved as a novel agent.

Zymfentra is also approved in Europe, where it's marketing under a different brand name. The product was developed by Celltrion, a Korean biopharmaceutical manufacturer that's shaping up to be a big player in the US biologics space. Zymfentra's subcutaneous presentation allows for easier and more convenient self-administration for patients, particularly those with inflammatory bowel disease (IBD), an umbrella term for ulcerative colitis and Crohn disease.

Zymfentra is also unique in that it was approved using data from 2 trials testing the product vs placebo in patients with ulcerative colitis and Crohn disease. Typically, infliximab biosimilars are tested in patients with RA or PsA and receive extrapolated indication for gastroenterology conditions. The LIBERTY trials offer gastroenterologists who may be wary of a subcutaneous infliximab option a degree of confidence that Zymfentra is safe and effective for patients currently on intravenous infliximab treatments.

We spoke with Andres Yarur, MD, a researcher on the LIBERTY trial and an associate professor of medicine at Cedars-Sinai Medical Center, to discuss the significance of his trial, the approval of a subcutaneous infliximab option, and what both mean for the future of IBD care.

To learn more about the FDA approval of Zymfentra, 

To learn more about the results from the LIBERTY trials, 

On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).

The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur

On this episode, we will discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

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

On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.

Biosimilars Regulatory Roundup for September 2023—Podcast Edition

The newest field of health care to experience biosimilar competition is the ophthalmology space, particularly the retinal disease treatment sector. Currently, the United States and the United Kingdom each have 2 ranibizumab biosimilars and the European Union only has 3, all of which were approved in the last 2 years. Additionally, more ranibizumab biosimilars referencing Lucentis and a slew of aflibercept biosimilars referencing Eylea are expected to enter the market over the next few years. Although all data shows these products to be bioequivalent to their reference products, the lack of real-world evidence around the world has left many ophthalmologists and biosimilar experts struggling to gain clarity on the safety of these products.

Furthermore, there is even more confusion about the meaning of interchangeability after 1 ranibizumab product (Cimerli) was granted an interchangeability designation by the FDA despite the label only applying to products dispensed through pharmacies and the label being granted without requiring data from a switching study.

Today, I’m joined by Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars, to discuss these issues and the FDA’s efforts to instill public confidence in ophthalmology biosimilars. Dr. Yim has worked extensively to help create the FDA’s education material on biosimilars and spread the FDA’s view that biosimilars are as safe and clinically effective as their reference products. 

Prior to her work at the FDA, she was a clinical fellow at the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Disease and served as a medical officer for the US Army for over 10 years. She also hosted the FDA’s workshop on increasing efficiency within biosimilar development programs, presented at the DIA Biosimilars Conference, and was a featured panelist for our most recent LinkedIn Live event on ophthalmology biosimilars last fall.

To check out part 1 of this interview series (written Q&A with Samsung Bioepis’ Kyung-Ah Kim), 

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, 

To learn more about ophthalmology biosimilars, 

To learn more about clinical efficacy testing, 

To learn more about our LinkedIn Live event on ophthalmology biosimilars, you can 

To check out the FDA’s overview page on biosimilars, 

To check out the FDA’s patient-focused biosimilar education materials (English and Spanish versions), 

To check out the FDA’s biosimilar education materials for health care professionals, 

For more information on the FDA's biosimilar curriculum, 

For more information on the FDA's free CE courses on biosimilars, 

 and use the filter function to select biosimilars.

On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.

Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology Biosimilars

On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.

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?

Biosimilars Regulatory Roundup for November 2022—Podcast Edition

This episode is going to be recapping some of the biggest regulatory events to happen in the biosimilar space during the month of August, including 2 European approvals, 2 US approvals, including 1 for an interchangeable biosimilar, and the advancement of the Inflation Reduction Act of 2022.

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

On this episode of Not So Different, we look back at some of the biggest regulatory events to happen in the biosimilar space during August, including 2 European approvals, 2 US approvals, and the advancement of the Inflation Reduction Act of 2022.

Biosimilars Regulatory Roundup for August 2022—Podcast Edition

On this week’s episode, we’re breaking down the possible impact that Humira biosimilars will have on health policies across the United States. Come 2023, the United States will welcome at least 7 biosimilars referencing Humira (adalimumab) to the market, catapulting the adalimumab market to the number 1 spot as the biosimilars space with the most competitive products referencing the same molecule. One of the biggest concerns regarding these launches is how providers, practices, and payers are going to adapt to ensure that patients have access to adalimumab biosimilars and that practices aren’t overwhelmed trying to keep up with multiple versions of the same product.

The Center for Biosimilars spoke with Chronis Manolis, senior vice president of pharmacy at UPMC Health Plan. He has a lot of experience working in the health plan space, especially regarding policy and relationships with pharmacy benefit managers, a rather contentious topic in present day biosimilar discussions. Manolis is also a proponent of the idea that providers and payers could work together to promote biosimilar use and has been keeping eye on the developing adalimumab space.

To learn more about the hype regarding adalimumab biosimilars in the US, 

To see which biosimilars have been approved by the FDA, 

To read more on PBMs and their influence on biosimilar uptake, 

On this podcast episode, The Center for Biosimilars spoke with Chronis Manolis from UPMC Health Plan to discuss how health care policies may shift as adalimumab biosimilars referencing Humira come to market in 2023, including how providers and payers can ensure equitable access.

Not So Different: How Health Policies May Take Shape in a Post-Humira-Exclusive Adalimumab Market

Eye on Pharma: Global Approvals, Launches, and Strategic Partnerships

FDA approves new denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases while driving competition and cost savings.

FDA Approves Amneal Denosumab Biosimilars, Capping Year of Market Expansion

Discover the top 5 regulatory biosimilar news of 2025, highlighting FDA approvals that enhance treatment options and competition in health care.

Denosumab, Golimumab Biosimilars Clear Major Regulatory Milestones in Europe, as US Hurdles Remain

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading claims in the competitive landscape.

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