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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

A Japanese study found high remission and continuation rates, plus non-inferior trough levels, after patients with IBD were switched to the infliximab biosimilar CT-P13.

Infliximab Biosimilar Maintains Remission, Trough Levels After Switch in IBD

Brooke McCormick is an assistant editor for 

Sandoz's Edward Li explains how biosimilar denosumab pricing could reshape cost-effectiveness, payer access, and gaps in osteoporosis care.

Biosimilar Denosumab Could Reshape Access, Costs in Osteoporosis Care: Edward Li, PharmD

Bevacizumab-to-biosimilar-to-branded transitions delayed nAMD care and cost more than direct switches.

Step Therapy to Biosimilars, Branded Anti-VEGF Costs More, Data Show

A study found no direct trial evidence for natalizumab or its biosimilar in MS and found limited cost-effectiveness vs most alternatives.

Natalizumab Biosimilar Shows Limited Cost-Effectiveness in MS

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

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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."

On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.

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

Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars and the feasibility of switching to them.

Eye on Pharma: Simlandi US Launch; Ranibizumab Partnership; Expanded Access for Adalimumab Biosimilars

DDW 2024 Posters Evaluate Safety, Efficacy, Impact of BMI on Zymfentra Use

Posters Demonstrate Switching Safety Between Originator, Biosimilar Infliximab in IBD

New Evidence Confirms Safe Biosimilar-to-Biosimilar Switching

Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD

Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings

Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar

Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.

Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition

Welcome to another insightful episode of Not So Different: a Podcast from The Center for Biosimilars. In this episode, we bring you detailed coverage of the trends, challenges, and insights gathered from the Festival of Biologics USA. 

Your host, Skylar Jeremias, assistant managing editor of The Center for Biosimilars

, and guest Dracey Poore, director of biosimilars at Cardinal Health, delve into the crucial themes that emerged from the conference discussions, mainly, the essential role of sustainability in the biosimilar industry. You'll hear about the forward thinking vision of the biopharmaceutical sector, as they maneuver through the evolving biosimilar landscape in their quest to make critical medications accessible to patients.

The conversation travels deeper into the biosimilar ecosystem as Poore explains the effect of significant challenges obstructing the widespread adoption and affordability of biosimilars. 

With insights from the richly detailed Cardinal Health Biosimilar Report, Jeremias and Poore guide you through the evolving prescriber trends and insights that influence biosimilar adoption alongside constructive strategies to overcome these hurdles. This episode sheds light on the importance of ongoing education, dismantling access barriers and promoting a competitive biosimilar market for a better health care landscape.

To read our coverage of the Cardinal Health report, 

To check out The Center for Biosimilars coverage of Festival of Biologics USA, 

00:03:48: Discussion on Cardinal Health Biosimilar Report and challenges to biosimilar adoption

00:04:48: Best practices for managing biosimilar inventories

00:08:05: Legislative efforts impacting the biosimilar landscape

00:10:38: Impact of payer preferences for reference products over biosimilars

00:13:36: Concluding thoughts on the future of biosimilars

Cardinal Health

The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.

Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report

Patent thickets, patent litigation, patent dances—all of these legal terms have plagued the biosimilar space, causing many biosimilar products to launch well after the originator's market exclusivity was supposed to expire. A perfect example of this is the Stelara (ustekinumab) space, where patent litigation settlements have led to delayed market access for ustekinumab biosimilars from late 2023 to early 2025. Additionally, congressional leaders have had to investigate AbbVie for potentially abusing the patent system to stall biosimilar competition for Humira (adalimumab).

But why does the system work like this? What can be done to improve it? What actions can be taken to ensure the patent system doesn't hinder competition and innovation?

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

To read more of Ha Kung's thoughts on the US patent system and its role in the biosimilar landscape, 

To learn more about Congress' role in addressing AbbVie's alleged anticompetitive practices regarding adalimumab products, 

To learn more about the suit filed by CareFirst BlueCross BlueShield regarding ustekinumab biosimilar delays, 

To learn more about the settlements that have resulted in the market delay of ustekinumab biosimilars, 

To learn more about lawsuits involving AbbVie that led to the delayed market entrance of adalimumab biosimilars, 

To learn more about what types of patents are at most to blame for biosimilar market delays, 

On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.

Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars

On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports  quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.

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

On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.

Biosimilars Gastroenterology Roundup for January 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

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

When it comes to the US biosimilar industry as a whole, adalimumab is on everyone's mind. 2023 ushered in a new age for these products and so far, 8 adalimumab biosimilars have entered the market and companies are looking for any way to stand out from the crowd. Some have chosen to use a dual pricing strategy to both get on formulary and offer steep discounts, some have chosen to align their prices more with the reference product (Humira), some are leaning on their interchangeability or high-concentration labeling in hopes of becoming the new preferred adalimumab option among pharmacy benefit managers and providers. However, whether these new biosimilars, if any of them, will gain significant market share or generate meaningful savings for Americans will remain to be seen.

Today, we're joined by Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, to discuss the initial market reaction to adalimumab biosimilars and her predictions for how the rest of the year will play out. Gregory recently published a paper claiming that adalimumab biosimilars will transform the US health care industry and she's been keeping a keen eye on how this is playing out in the real-world setting. She's also well-versed on the European and Canadian experiences with these products and can provide valued insight into how the United States' health system can champion the use of these products.

To read more about Dr. Gregory's commentary piece, 

To read more about Cardinal Health's 2023 Biosimilars Report, 

To learn more about adalimumab biosimilars, 

To learn more about the adalimumab biosimilars that have launched so far in the US:

 for the launches of Hyrimoz, Hadlima, Yusimry, and Cyltezo

On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.


Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?

July 2023—the moment the entire US biosimilar industry has been waiting for. This month 8 adalimumab biosimilars will launch on the market, and as of this recording, 7 have made their market debut. This represents the most biosimilars to launch in a single month and adalimumab is officially the drug class with the highest number of biosimilar options. These drugs all reference Humira, one of the most profitable drugs in the world, largely because it has 11 indications across the rheumatology, dermatology, immunology, and gastroenterology (GI) spaces.

In particular, adalimumab biosimilars open the doors for massive savings for patients with inflammatory bowel disease (IBD), an umbrella term for Crohn disease and ulcerative colitis. However, like other treatment spaces, the GI space must overcome misconceptions and misinformation regarding the safety and efficacy of IBD biosimilars, highlighting the need for more education resources for patients and providers alike.

Today, I'm joined by Laura Wingate, executive vice president, education, support and advocacy at the Crohn's & Colitis Foundation. She has been working with the foundation for over 16 years and has seen the market transform before her eyes as more gastrointestinal biosimilars enter the market. She is passionate about expanding access to IBD treatments and raising awareness about the emergence of IBD biosimilars, as well as their benefits and savings potentials.

To learn more about the adalimumab products that have launched in the US so far, click 

Laura Wingate, from the Crohn's & Colitis Foundation, explains some of the challenges regarding educating patients and providers on biosimilars for inflammatory bowel disease (IBD) as well as whether the gastroenterology space is ready for the influx of adalimumab biosimilars.

Adalimumab Biosimilars Take Center Stage: A Game Changer for IBD Treatment

Most pediatric and young adult patients with IBD maintained stable disease activity and laboratory markers after switching from the adalimumab originator. 

Nonmedical Adalimumab Biosimilar Switch Maintains Disease Control in Pediatric IBD

Sandoz moves toward US generic tirzepatide autoinjectors as FDA reviews ANDAs, signaling future GLP‑1 access amid patent and biosimilar gaps.

FDA Accepts Sandoz Generic Tirzepatide Applications Amid Biosimilar Development Gap

Early use of ustekinumab biosimilars in Spain shows cost-effective Crohn disease care, boosting QALYs and cutting NHS spend—insights for Europe.

Positioning Biosimilar Ustekinumab Early Reduces Burden on Spain's National Health System

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.

FDA Approves Immgolis and Immgolis Intri as First Biosimilars to Golimumab Reference Products for RA and UC

Tiago Biachi talking about GI biosimilars

During a recent interview at an Institute for Value-Based Care

Tiago Biachi, MD, PhD, assistant member at Moffitt Cancer Center and associate professor at the University of South Florida, emphasized that biosimilars are essential for enhancing the long-term sustainability of gastrointestinal (GI) cancer care by improving access to advanced treatments at lower costs.

He noted that rising health care expenses and the exclusivity of new drugs contribute to financial toxicity, significantly impacting patients’ quality of life. Biosimilars, particularly in cases of metastatic or advanced cancers requiring ongoing therapies, offer a pathway to equitable and affordable care. Biachi also underscored the importance of clinicians addressing treatment costs with patients and called for dynamic policies to streamline biosimilar development and adoption.

This transcript has been lightly edited for clarity.

How can biosimilars improve the long-term sustainability of GI care, especially in the context of rising health care costs?

Well, yeah, unfortunately, we're not doing a great job, for example, with screening or cancer in general. So if we don't screen for cancer, we're going to see more and more patients with advanced disease, where, usually, the treatment is more expensive. When we talk about new technologies, for example, for a diagnosis, or even new technologies for surgical treatment, of course usually they are going to add cost to the treatment. But usually the surgery, it's a 1-time procedure. Even, for example, circulating tumor DNA. Nowadays we have competition, with different companies providing this, and usually this is something that we're going to do every 3 to 6 months.

Tiago Biachi, MD, PhD, emphasizes that biosimilars are vital for reducing financial toxicity and ensuring equitable, affordable access to advanced treatments in gastrointestinal (GI) cancer care, while calling for dynamic policies and greater cost awareness among clinicians.

Gastroenterology

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