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WHEN CHOICE ARRIVES: Competition & Consequences

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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

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Council, break down one of the most consequential policy shifts in the biosimilar landscape in years: the FDA’s new draft guidance on comparative efficacy studies (CES) and interchangeability.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

Explore the evolving biosimilars landscape with expert insights on development, regulation, and global health harmonization in this engaging podcast episode.

Follow the Science: Bridging the Biosimilar Gap With Dr Hillel Cohen

In this insightful podcast episode, host Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), welcomes former Sandoz executive and biosimilar expert Hillel Cohen, PhD, to discuss the evolving world of biosimilars. The conversation covers the scientific and regulatory landscape, touching on the progress in streamlining biosimilar development, the importance of following scientific advancements, and the potential for harmonization in global health regulations.

This special vodcast series provided by The Center for Biosimilars

 was developed in partnership with the AAM and Biosimilars Council. Check out 

 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.



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

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."

 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. 

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?

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

FDA Approves Pavblu for Retinal Conditions

AAM Report: Generics and Biosimilars Savings Reach $445 Billion in 2023, Part 1

Expanding Biosimilar Adoption: Insights and Strategies With Dr Sophia Humphreys

The Future of Biosimilar Gene Therapies: Key Issues and Potential

IRA Reimbursement Impact on Biosimilars Minimal Despite Rising Market Share

The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings

France Study Finds High Patient Satisfaction With Adalimumab Biosimilar Treatment for IBD

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.


Biosimilars Policy Roundup for September 2024—Podcast Edition

On this episode of Not So Different, we review all the big biosimilar policy news from July, including discussions regarding biosimilar policies, in both the US and abroad, as well as 3 highly anticipated FDA approvals.

FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara

Ahzantive Receives FDA Approval as New Eylea Biosimilar

FDA Approves Epysqli as Second Soliris Biosimilar

BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed

Biosimilars and Employers: Strategies for Success

Learning the Lingo of Biologics and Biosimilars Is Critical

Singapore Experience Shows Benefits of Value-Driven Strategies in Generating Biosimilar Savings

Approximately Half of Patients Demonstrated Poor Health Literacy Prior to Biosimilar Switch

Biosimilars Policy Roundup for July 2024—Podcast Edition

On today's episode, we'll dive deep into the US biosimilars market landscape, a topic of growing importance as biosimilars offer significant potential for reducing health care costs and increasing access to life-saving therapies. Understanding the current legislative and regulatory environment is crucial, as it shapes the approval and adoption processes for biosimilars. We'll explore key factors affecting payer uptake and provider adoption of biosimilars in the US, such as economic considerations, clinical evidence, and market dynamics. These factors are vital for stakeholders aiming to effectively navigate the complex biosimilars landscape. Additionally, we'll examine the challenges and opportunities associated with biosimilars for stakeholders across the health care continuum, including manufacturers, payers, providers, and patients. Addressing these challenges and leveraging opportunities can enhance the impact of biosimilars on health care systems and patient outcomes, making this discussion essential for anyone involved in the health care industry.

Today, we're joined by Kyle Noonan, PharmD, MS, is a highly qualified expert who supports scientific and commercial consulting engagements at Cencora, helping manufacturers demonstrate the clinical and economic value of their products. His work includes outcomes research strategy, pre-approval information exchange, payer value proposition development, primary market research, pricing research, and market access strategy.

Dr. Noonan has a diverse background with experience in various health care settings, including medical affairs within the biopharmaceutical industry, association management, consulting, and clinical trial research. He has extensive leadership experience with the Academy of Managed Care Pharmacy (AMCP) and has presented numerous posters at AMCP conferences. Dr. Noonan holds a Doctor of Pharmacy from Mercer University and a Master's in Pharmaceutical Outcomes and Policy from the University of Florida.

To learn more about Cencora and their efforts, 

To learn more about the Inflation Reduction Act's impact on biosimilars, 

Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.








Biosimilars in America: Overcoming Barriers and Maximizing Impact

On this episode of Not So Different, The Center for Biosimilars

 glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

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

On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

Biosimilars Policy Roundup for April 2024—Podcast Edition

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

At Asembia 2023 in Las Vagas, Nevada, Tasmina Hydery, associate director of Digital Solutions at AmerisourceBergen, presented on the future of the biosimilars industry as well as how payers have responded to the influx of new biosimilar products in the United States. During the session, she shared results from AmerisourceBergen's report on the biosimilars pipeline, sharing survey results on how payers place biosimilars on formularies, their views on interchangeability, and their use of prior authorization and step therapy strategies to encourage providers to prescribe preferred products.

On today's episode, we spoke with Tasmina and her colleague, as well as a returning guest on the Not So Different podcast, Brian Biehn, senior director of Biosimilar Commercialization at AmerisourceBergen, about some of the points brought up during the presentation and some of the pricing trends that we're seeing in the space.

To learn more about Tasmina's Asembia 2023 presentation, 

AmerisourceBergen Biosimilar pipeline report

To listen to Brian's past appearance on Not So Different, 

Asembia

On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.

What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends

Biosimilar competition significantly reduces out-of-pocket costs for Medicare patients, enhancing affordability for biologic therapies and improving access.

Biosimilar Competition Linked to Lower Out-of-Pocket Costs for Medicare Patients

Australia's biosimilar adoption significantly reduces biologic medicine costs, enhancing access while maintaining utilization amid tighter health care budgets.

What Australia’s Experience Reveals About Biosimilar Adoption and Pricing

GBW 2025 webinar

Health care systems around the world are facing increasing challenges—from rising costs to gaps in access. Biosimilar medicines offer a promising solution, helping make care more accessible, affordable, and sustainable for patients everywhere. These goals align closely with the United Nations’ Sustainable Development Goals for Health by 2030, and today’s discussion will explore how biosimilars can help make that vision a reality.

This webinar is part of the sixth Annual Global Biosimilars Week, running from November 3 to 7, 2025. The theme this year—“Biosimilars: A Wise Investment for Global Health”—perfectly captures the spirit of this conversation and the opportunities ahead.

, senior director of biosimilar policy and science at Medicines for Europe (moderator)

, global lead, Non-Communicable Diseases, PATH Coalition

, clinical pharmacist (Endocrine/Diabetes) at the Endocrine Institute at Hospital Putrajaya in Malaysia

, director of regulatory affairs at Sandoz Mexico

, director of thought leadership at IQVIA

, oncologist at the University Hospital Bristol NHS Foundation Trust in the UK

, senior advisor in the Division of Access To Medicines and Health Products (MHP) for the World Health Organization (not shown)

These were questions asked by the audience during the live broadcast of the webinar. The speakers provided responses after the webinar ended. Below are their responses and insights.

Are there examples of biosimilar-driven access improvements that could be replicated in other regions?

There are examples available in the IGBA Biosimilar Access Policy Blueprint (2021) as well as in IGBA Biosimilar Communication Resources (Module 5 - The benefits of biosimilar medicines). Translating the biosimilar availability opportunity into tangible access development is always a matter of policy framework and policy interventions that transform the cost-effectiveness gains into investment in better use of resources and more efficient processes.

The 2024 NCD Best Buys report aims at supporting WHO member states to prioritize and scale up the implementation of the most impactful and feasible interventions in the national context. Off-patent medicines, including biosimilar medicines, are part of the best buys. Could you tell us more about the overall progress so far to meet the 2030 goals? (Are we on course? Are we delayed?)

The target established by WHO is for 80% availability. While there has been movement, it is not even across all regions and also varies between the private and public sectors, with private sector availability being slightly higher. The ranges are 38-68% in the public sector and 42% to 77% in the private sector. Some of the challenges are high prices, where many countries pay higher amounts than the international reference price, including both acute and chronic conditions, and where also there is increasing dependency on out-of-pocket payments.

In Mexico, will the government be adopting a streamlined biosimilar development pathway that removes the requirement for phase 3 (comparative efficacy) studies?

Currently the requirements by the local rules include the requirement for clinical trials to demonstrate efficacy and safety. In Mexico, the biosimilars are called biocomparables. Below there is more detail about it.

In my experience, the requirements related to clinical trials are case-by-case; in the end, the opinion of the New Molecules Committee and Biotech Products Evaluation Subcommittee (NMC/BPES) will determine the specific requirements for approval of each biocomparable biotechnological medicine. This opinion is based on the documentation presented in the CTD modules 2, 3, 4, and 5. During my presentation, I also mentioned that for biosimilars, the presubmission meeting before NMC/BPES is mandatory.

For biosimilars, below I have described some preclinical and clinical requirements indicated in the local rules, but this can be extended case by case:

“...The application must include the documentation outlined in Sections I to IX of Article 177, as well as preclinical and clinical studies such as:

Any other studies determined by the Ministry, based on the opinion of the New Molecules Committee.”...

“...III. Reports of preclinical studies in animals must include comparative data between the reference biotechnological medicine and the biocomparable product. These studies must be conducted in relevant animal species and include, as determined by the New Molecules Committee:

Comparative pharmacokinetic study reports, when required by the Ministry, to demonstrate pharmacokinetic biocomparability between the biocomparable and reference products, based on key parameters.”...

How many biosimilar products have been approved through reliance pathways in Mexico so far?

This data is not available. However, in my presentation I mentioned that during almost 4 years the reliance applied to participate in tenders without MA issued by COFEPRIS, applicable only for tenders to supply public institutions Therefore, some products that participated with MA issued by recognized authorities could be identified during the tender processes (small molecules and biosimilars), but there is no official data about the total number of biosimilar products approved through reliance pathways.

In the future, probably based on the last publication in July 2025, for the application of the abbreviated regulatory pathway (equivalence agreements), the approvals might be differentiated.

Regulatory convergence is improving among EMA, FDA, and WHO, but not all dossiers will meet these new standards.Will companies need to conduct new studies, and how might that affect costs or timelines?

 entitled “Developing a Regulatory Policy Framework Supporting Biosimilar Competition: The Opportunity for Tailored Clinical Biosimilar Development” where 2 important points were made:

A global regulators roadmap towards streamlined biosimilar development program should be adopted - maintaining the scientific and regulatory rigor is needed to support approval, and allow for tailored clinical development.

The role of regulators extends beyond approval to include education for healthcare professionals to understand the analytical science that underpins biosimilarity, ensuring that regulatory approval translates to utilization of biosimilar medicines.

Today, in 2025, both remain cornerstone to harvesting the benefits of streamlined development. The asynchrony of adoption of the new standards will require developers to at best maintain extended developments (including unnecessary studies) or worst to have 2 developments for the different jurisdictions, although this is unlikely to be retained as a viable option. This points to all international regulatory convergence initiatives (eg, ICH, IPRP, ACCESS consortium) as key drivers for access.

A significant evolution of the regulatory requirements in underway in the global regulatory community (so called streamlined clinical development) offering the perspective of biosimilar developments for more biologic medicines. How can the WHO efforts be amplified, notably in promoting harmonisation of standards (through the guidelines and their implementation) or through collaborative or reliance initiative?

Policy

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