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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job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

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."

 focuses on the critical issue of cost-related nonadherence in biologic treatments and the role of biosimilars in delivering promised savings. Despite the FDA approving 68 biosimilars, they currently make up only 2% to 3% of the U.S. biologics market, with market share varying significantly between individual markets, ranging from 8% to 82%.

Biosimilars have, however, demonstrated significant cost savings over the past decade. According to data from the Association for Accessible Medicines (AAM), generics and biosimilars collectively saved the U.S. a total of $445 billion by the end of 2023. Biosimilars alone accounted for $12.4 billion in savings in 2023, bringing total savings to $36 billion since their introduction in 2015. Despite these savings, barriers remain, as many biologics set to lose patent exclusivity in the coming years lack biosimilars in development. Addressing cost-related nonadherence and leveraging artificial intelligence (AI) to streamline prescribing processes and increase biosimilar utilization are key topics of discussion.

Josh Canavan, head of pharmacy at RazorMetrics, provides insights into why, despite the substantial savings biosimilars offer, they still represent only 23% of the overall biologics market. The conversation explores how AI-powered tools are assisting physicians in transitioning to biosimilars, enabling patients to access life-saving treatments at a fraction of the cost. As the 10th anniversary of the first biosimilar approval is observed, the discussion highlights the importance of automation, policy reforms, and increased adoption to bridge the affordability gap and expand patient access to these critical treatments.

To learn more about the 10th anniversary of the first FDA biosimilar approval and current insights into the biosimilar industry, 

To learn more about how much biosimilars have saved so far, 

To read more about Josh's views on the pharmaceutical landscape in 2025, 

Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?

How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment

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 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

In today's episode, we'll be diving deep into the crystal ball, exploring predictions for how advancements from the past year will shape the biosimilar market in 2024 and beyond. With approvals, advancements, and regulatory shifts, the landscape of biosimilars is constantly evolving. And who better to provide us with insights into these changes than our returning guest, Julie Reed, executive director of the Biosimilars Forum?

We'll be delving into the impact of recent developments on market dynamics, discussing how these advancements are reshaping strategies, influencing investment decisions, and ultimately, transforming patient care. From the first on-body pegfilgrastim biosimilar to the growing acceptance of adalimumab biosimilars, we'll dissect the key trends and their implications for the future. But it's not just about looking back; it's about looking forward. Julie will be sharing her predictions for what lies ahead in the biosimilar market. What regulatory challenges can we anticipate? How will market access evolve? And what role will innovation play in driving the next wave of biosimilar adoption?

With Julie's expertise and insights, we'll gain a deeper understanding of the forces shaping the biosimilar landscape and uncover strategies for navigating the opportunities and challenges that lie ahead.

For more information on the Biosimilar User Fee Amendments III (BsUFA III), 

For more information on the 1-year anniversary of adalimumab biosimilars in the US, 

To listen to more of Julie Reed's thoughts on the US biosimilar industry and streamlining development, 

To learn more about the Biosimilars Forum, 

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.

Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024

On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.

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

Biosimilar Business Roundup for October 2023—Podcast Edition

On this episode, we’re going to be giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.

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

On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.

Biosimilars Business Roundup For August 2023—Podcast Edition

With US' market experience with biosimilars approaching a decade, industry experts are beginning to look into ways to accelerate biosimilar development to make more lower-cost products available to patients quicker. Strict regulatory guidelines require manufacturers to conduct numerous expensive and time-consuming preclinical and clinical trials to obtain approval and prove that biosimilars are safe and effective. However, research has shown that not all of these tests may be necessary anymore and there's might be ways to cut down on development spend without compromising safety.

A commentary paper written by 4 representatives from pharmaceutical companies sought to provide an unbiased perspective on this objective can be achieved, noting that extensive testing was needed when biosimilars were new but approval requirements should be updated as the industry gains new information.

Today, I'm joined by Julie Reed, executive director of the Biosimilars Forum, a nonprofit organization aimed at the advancement of biosimilar adoption through collaboration with biosimilar manufacturers. The companies that the paper's authors represent (Samsung Bioepis, Sandoz, Boehringer Ingelheim, and Fresenius Kabi) are all members of the Forum and our discussion with Reed will highlight some of the major pieces from the paper and next steps for the industry to propel biosimilar development into the future.

To register for the FDA's workshop on streamlining biosimilar development, 

To learn more about the Biosimilars Forum and its members, 

To read the IQVIA report cited in the paper, 

On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.

How Streamlining Development Can Save the US Biosimilar Industry

On this episode, we’re going to be recapping some of the biggest stories in the business space regarding biosimilars, including adalimumab preparation, partnerships for commercialization, and more.

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

Biosimilars Business Roundup for June 2023—Podcast Edition

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

Biosimilar partnerships and EU approvals surge, enhancing access to innovative treatments in immunology, oncology, and bone health markets.

Biosimilar Market Momentum: EU Approvals, Strategic Launches, and Major US Partnerships 

The latest advancements in global biosimilar access include new treatments, strategic partnerships, and competitive market entries enhancing patient care.

Global Biosimilars Market Sees Gains in Access and Pipeline Expansion 

Biosimilars and generics drive significant health care savings, yet a concerning lack of biosimilar development for biologics set to lose exclusivity in the next 10 years threatens future access and affordability.

Biosimilars Drive Savings and Access, Yet Looming Development Gap Threatens Future

global biosimilars week webinar

 was hosted by The Center for Biosimilars

 in partnership with the International Generics and Biosimilars Association.

Global Biosimilars Week (GBW) 2024 is an annual campaign designed to raise global awareness about biosimilar medicines and their role in improving patient care and access to affordable treatment options.

This year’s theme, "Advancing Access to Biosimilars," focuses on the progress made over the past two decades surrounding approval, market acceptance and adoption of biosimilars—as well as the challenges that remain in expanding access worldwide. With an effort to highlight the importance of collaboration among health care professionals, patients, stakeholders, and policymakers, the webinar will focus on 

 to advance access to biosimilars and will feature expert discussions on the key barriers to biosimilar uptake in different regions and explore strategies to overcoming these obstacles.



Current global trends in streamlining biosimilar regulatory requirements to foster efficient adoption and market growth.

Strategies to address challenges and improve biosimilar access.

The role of biosimilars in promoting health care sustainability and better patient outcomes.

, assistant managing editor of The Center for Biosimilars (host)

, senior vice president of sciences and regulatory affairs, Association for Accessible Medicines (moderator)

, PhD, Executive Director for Products Evaluation and Standards Setting, Saudi Food and Drug Authority

, PhD, scientist, technical standards and specification unit group lead, norms and standards for biologicals, Health Product Policy and Standards/Medicines and Health Products/World Health Organization 

enior quality specialist, European Medicines Agency

, director, Office of Therapeutic Biologics and Biosimilars Office of New Drugs, Center for Drug Evaluation and Research, FDA

Videos

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

global biosimilars week webinar in partnership with IGBA

Where Do Biosimilars Fit into the Cancer Treatment Puzzle?

The incidence of cancer is expected to increase to 30 million patients worldwide by 2040. However, the introduction of biosimilar medicines, both as treatment and supporting therapy for cancer patients, has created a significant opportunity to make cancer care more accessible, thereby improving patient outcomes and reducing the health care burden globally.

Everyone across the world involved in the fight against cancer—including patients, health care workers, policymakers, and governments—was invited to take part in IGBA’s Global Biosimilars Week 2023 webinar. During the event, discussions focused on how all stakeholders could collaborate to expand global cancer care, with a special emphasis on the role of policies related to biosimilar medicines.

IGBA’s fourth annual Global Biosimilars Week (GBW) is taking place from  November 13-17, 2023. The mission of this online, social media–focused campaign was to raise awareness of the powerful and life-changing impact of biosimilar medicines. The theme this year is "Making Cancer Care More Accessible to Patients and Healthcare Systems."

 is a proud media partner for GBW and collaborated with IGBA to host this webinar.

, cancer control officer, World Health Organization

, director of policy and advocacy, Lymphoma Coalition

, consultant pharmacist at The Royal Marsden NHS Foundation Trust and member of the International Society of Oncology Pharmacy Practitioners (ISOPP), United Kingdom

, member of the Biosimilar Medicines Committee, IGBA

Skylar Jeremias, senior editor at The Center for Biosimilars

In partnership with The Center for Biosimilars®, the International Generic and Biosimilar Association hosted a live webinar, where panelists gathered from around the globe to discuss benefits as well as major barriers and accessibility challenges associated with oncology biosimilars worldwide. 

Webinar: Where Do Biosimilars Fit Into the Cancer Treatment Puzzle?

Although a "generic-like" model may be preferable to stakeholders, the United States has a long way to go to get the biosimilars market to reach that point, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, at Asembia 2023.

Will the biosimilars space evolve into a more "generic-like" marketplace or will beiosimilars behave more like reference products?

Yeah, that's a really good question too! Right now, we are seeing biosimilars behave a little bit more like reference products. We're seeing them being treated differently on formularies. We're seeing them come to market with slight variations.

The adalimumab biosimilars are a great example of why they're not exactly like generics. There's variability in biologics in general. So, of course, there's variability in biosimilars. Not only is there innate variability, there's also some slight differences in some of the makeup of these products.

For example, with adalimumab, we have citrate-containing and we have citrate-free, we have high-concentration, we have low-concentration, we have different administrative devices that patients might view as better than others. So, there are a few things that are different about biosimilars and biologics in general that aren't present when we think about simple molecule generics that are all exactly the same.

While we would like biosimilars to look more like generics eventually, there are several things that we kind of have to evolve to get to that place.

Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses what the future biosimilars marketplace may look like compared with generics and reference products at Asembia 2023.

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