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Articles

Between congressional hearings and executive orders, experts had plenty to draw on when dissecting the barriers to biosimilar access at Festival of Biologics USA to close out April 2025.


Biosimilars Policy Roundup: April 2025

Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.

Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships

Cameron Santoro is an associate editor for The Center for Biosimilars

Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA. 

FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access

A plain language summary for patients explains there were no differences in safety outcomes between adalimumab-adbm and the originator in a pooled analysis of the VOLTAIRE clinical trials.

Clinical Evidence Shows No Safety Gaps Between Biosimilar, Reference Adalimumab

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Business & Practice

On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.

1. Jeremias S. Strengthening the supply chain: key insights from FDA commissioner Dr Robert Califf. The Center for Biosimilars®. October 25, 2024. Accessed November 1, 2024. 

https://www.centerforbiosimilars.com/view/strengthening-the-supply-chain-key-insights-from-fda-commissioner-robert-califf

2. Jeremias S. FDA and industry experts unpack biosimilar device requirements. The Center for Biosimilars. October 23, 2024. Accessed November 1, 2024. 

https://www.centerforbiosimilars.com/view/fda-and-industry-experts-unpack-biosimilar-device-requirements

3. Jeremias S. Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims. The Center for Biosimilars. October 23, 2024. Accessed November 1, 2024. 

https://www.centerforbiosimilars.com/view/calling-for-unified-biosimilar-standards-stronger-education-at-grx-biosims

4. Jeremias S. Unifying standards: the need for streamlined biosimilar development. The Center for Biosimilars. October 22, 2024. Accessed November 1, 2024. 

https://www.centerforbiosimilars.com/view/unifying-standards-the-need-for-streamlined-biosimilar-development

5. Jeremias S. Enhancing Adoption of Infused Biosimilars for a Sustainable Future. The Center for Biosimilars. October 30, 2024. Accessed November 1, 2024. 

https://www.centerforbiosimilars.com/view/enhancing-adoption-of-infused-biosimilars-for-a-sustainable-future

6. Jeremias S. IQVIA webinar: enhancing regulatory strategies for biosimilars and generics. The Center for Biosimilars. October 14, 2024. Accessed November 1, 2024. 

https://www.centerforbiosimilars.com/view/iqvia-webinar-enhancing-regulatory-strategies-for-biosimilars-and-generics

Biosimilars Development Roundup for October 2024—Podcast Edition

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

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

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

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

Recently, Amgen released the latest update to its Biosimilar Trends Report, detailing some of the big successes for biosimilars in the United States since their market introduction in 2015 as well as current market trends, predictions for the next phase of biosimilar competition, and advice for stakeholders going forward. The report also gave insight into how biosimilar policies, such as reimbursement structures, could develop in the future and whether the United States is heading towards greater biosimilar adoption.

On this episode, I’m joined by Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen. Chad is a long-time friend of The Center for Biosimilars, having spoken to us in video interviews in the past about previous version of this report. He was also a recent panelist at the DIA Biosimilars Conference that was held in September 2022 and has been working with Amgen since 2000. He’s been working to advance biosimilars since 2014 and is considered a market expert on the biosimilars industry.

To read more about Amgen’s Biosimilar Trends Report, click 

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

To see more of Chad’s takeaways from older version of Amgen’s Biosimilar Trends Report, click 

To learn more about tender systems, click 

To check out the last episode of Not So Different, click 

Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen, discusses the most recent version of Amgen's Biosimilar Trends Report and what the report says about the current biosimilar market and how it could develop in the years to come.

What Amgen’s Biosimilar Trends Report Says About the Future of Biosimilars

Despite some biosimilars, including those for filgrastim, trastuzumab, and bevacizumab, achieving a greater US market share than their originators, other biosimilar categories, such as pegfilgrastim and infliximab, are still trailing behind. Some biosimilar companies are becoming more savvy, developing new ways to make a bigger statement in the market.

We sat down with Kirollos Hanna, PharmD, the manager of Oncology Pharmacy at the University of Minnesota Medical Center, an associate editor for the Journal of the Advanced Practitioner in Oncology, and an assistant professor at the Mayo Clinic School of Medicine, to discuss what tactics biosimilar companies are using to better compete alongside originator manufacturers.

Kirollos Hanna, PharmD, from the University of Minnesota Medical Center, discusses some of the tactics that biosimilar companies are employing in order to level the playing field and better compete against originator companies.

Not So Different: How Biosimilar Companies Are Stepping Up Their Game to Compete Against Originators

Although the European Union has been in the biosimilars game longer than the United States, both are considered leaders in biosimilar use. Generics were the first copycat drugs, however, there are lessons to be learned from this experience. But biologics, which are made from living organisms, are not as simple to copy as generics are. There will be minute differences between biosimilars and originator biologics, and there will even be small differences between different batches of the same originator biologic. We now have reliable tests for determining whether these differences are clinically significant or not. But what does our experience so far with biosimilars and originators tell us about these differences?

We sat down with Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, Zarxio, a filgrastim product developed by Sandoz. Paul helped explain these issues.

To hear more from Paul on biosimilar issues, click 

To read about Paul’s insight on the current issues in the Indian biosimilar market, click 

Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert, explains the relevance of differences between biosimilars and reference biologics. 

Not So Different: Should Biosimilar Variations Be Concerning?

Shanghai Henlius Biotech is a growing China-based biopharmaceutical manufacturer that’s been working in the biosimilars space for some time. The company recently got approval for their 40 mg/ml low-concentration adalimumab biosimilar in December 2020 and is currently focused on marketing that in China. They have a plan to develop a high-concentration adalimumab biosimilar in the future to compete alongside AbbVie’s high-concentration formulation of the reference product, Humira. The company is also in the process of developing biosimilars for programmed death-1 (PD-1) inhibitors, which are used to treat several types of cancers.

We sat down with Ping Cao, vice president of Business Development for Henlius, to discuss the company’s current biosimilar development plans and how the regulatory process in China differs from those of Europe and the United States.

To hear more comments from Ping Cao, click 

To learn more about Henlius’ development plans, click 

To learn more about Henlius’ approval for their adalimumab biosimilar, click 

To learn more about PD-1 inhibitors, click 

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

Not So Different: How Henlius is Making Its Mark on the Global Biosimilar Industry

Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.

BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars

Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.

BioRationality: Commemorating the 15th Anniversary of the BPCIA

Alvotech's 427% revenue surge in 2024—fueled by its biosimilar portfolio and global expansion—highlights the booming profitability of biosimilars despite financial hurdles.

Biosimilars Help Alvotech Revenues Soar Over 400% Year Over Year

Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.

BioRationality: How Developers Can Expand Their Monoclonal Antibody Biosimilar Portfolio

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

Videos

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?

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, highlights the importance of his study comparing an adalimumab (Cyltezo) with the refrence product (Humira) patients with gastroenterology conditions.

What role can your trial play in improving patient and provider confidence in using adalimumab biosimilars for Crohn disease and ulcerative colitis?

The study actually provides additional reassurance regarding the biosimilarity and the potential of patients switching from either the [reference product] to the biosimilar or substituting the biosimilar from the onset.

Why are more clinical studies on anti-TNF [tumor necrosis factor] medications in gastroenterology conditions needed and how can providers and health systems be better advocates for these types of trials? 

Firstly, there still is room for improvement in efficacy within the TNF class. We're not getting 100% remission rates and we know that remission rates can be improved with the addition of immunomodulators for instance, or dose escalation in some situations. In addition, we are seeing newer TNF formulations—for instance, of subcutaneous infliximab—as a maintenance therapy. So, as additional biosimilars are coming out, we also have additional new products of the same class that are being evaluated and offer patients different opportunities, for instance, of intravenous versus subcutaneous formulations at different intervals.

Stephen Hanauer, MD, professor of medicine, Feinberg School of Medicine, Northwestern University, shares why his study comparing the safety and efficacy of Cyltezo, an adalimumab biosimilar, with the originator (Humira) matters for patients with gastroenertology conditions.

Dr Stephen Hanauer: Why More Studies Assessing Adalimumab Biosimilars in Gastro Conditions Are Needed

Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science, made predictions on what will drive biosimilar uptake and savings over  the next 5 years using the data from 

IQVIA's Biosimilars in the United States 2023-2027 report

 at Access!, the annual meeting of the Association for Accessible Medicines in Orlando, Florida.

The latest IQVIA Biosimilars in the United States report predicted that spending on biosimilars will increase to $129 billion and generate $180 billion in savings over the next 5 years. What are going to be some of the biggest drivers for these numbers going forward?

Obviously, the biggest drivers in the next few years are adalimumab biosimilars. But there's other products in the same category: ustekinumab (Stelara) biosimilars is coming very soon. There's also some other areas, like age-related macular degeneration. So, ranibizumab and following slight thereafter is aflibercept. 

But we have a an outlook with a number of these medicines that we think are going to have a reasonably big impact on the dollars going to the biosimilars, as well as to the savings. We also profile a significant set of uncertainties we feel like in terms of the uptake and the different behavior of individual companies in marketing the biosimilars. How competition has so far worked out in terms of the concentration in the market. 

Imagine a circumstance where there's a large number of companies challenging one particular molecule and not all of them make their return. The sustainability of the market for biosimilar makers is a key question, as well as the sustainability if biosimilars are not entering the market or are lower selling than originators. So, a lot of questions that really frame the future of this sector where there are 300 or so molecules that are biologics, and so far, we have 39 of them with approvals or are in the pipeline, and many more that have not yet begun that journey; it's unclear how many will.

The report focused a bit on the US market introduction of up to 10 adalimumab biosimilars, including Amjevita, which just launched at the end of January 2023. How do you anticipate this portion of the biosimilars market developing through 2027 and what are going to be the main factors driving utilization trends for these products?

The thing that we include in a couple of the exhibits in the report is is an assessment of the adalimumab market for a couple of key dynamics. 

One, you mentioned, is the number of challengers, but the other is the nature of the originator. Subsequent to the original launch of adalimumab, there have subsequently been reformulations, with a high-potency and citrate-free formulation and a significant migration of the current patients to this newer formulation. Not all of the biosimilars are formulated the same way. There is a difference in the administration a patient would experience and perhaps those benefits are valuable to patients and providers. 

So, there's definitely a question of essentially as an analog, when we think about what adalimumab is doing in terms of continuing to move that innovator forward, how that has played out in other molecules when we see that in filgrastim and pegfilgrastim. When we see that in the breast cancer market with trastuzumab and other related products from the originators [Herceptin]. The relevant market of the originator that the biosimilar is similar to may not be the same when we get our biosimilars to the market as it was when the development program started. 

Understanding how that market is going to evolve and whether the value of subsequent innovations is telling, or whether the cost savings is the telling feature, all of those are influenced by the negotiating power of the different participants. The more challengers there are, the more game theory comes into play and the more nuanced and generally the deeper the price erosion and volume erosion tends to be. 

Fewer competitors tends to result in lower price discounting as well. And those are patterns that we've seen go back to small molecules and back to the beginning of the H

 So, we should expect to see many those things come out. But it's going to be interesting to see what the participants do. 

Probably my key observation on this is the way in which the originators participate in these markets. We've seen a mix. Historically, we've seen originators essentially exit—not lower their price post expiry, not compete on price with the biosimilars essentially. We've also seen them lower their price and essentially compete for the volume and the contracts after the presence of biosimilars. 

Those will have an effect, and there is a scenario you can imagine where this system, society as a whole, saves money because of the presence of biosimilars but the biosimilar maker isn't rewarded for it commercially. That could be one of the outcomes we see here; it's a lot of money that we're talking about. These are big selling products sometimes. The amount to play for is certainly motivating and that's why you're seeing, as you said, as many as 10 competitors, and some of the other products have a similar number.

Adalimumab and ustekinumab biosimilars aren't the only factors that will drive biosimilar adoption and savings through 2023, according to Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.

Conference

What Will Be the Major Drivers Behind IQVIA's Predicted Biosimilars Uptake, Savings?

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, gives his thoughts on the necessity of clinical efficacy testing for biosimilar approvals, switching studies to establish interchangeability, and the promotion of biosimilars within company environmental and social impact reports.

Lately, there have been a number of efforts to try to remove clinical efficacy testing for biosimilars and to remove switching study requirements for establishing interchangeability. What is Biogen’s view on these efforts and do you think removing these requirements would create more confusion about biosimilar safety?

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.

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