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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

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FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

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

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

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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

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

Denosumab biosimilars enhance treatment access for postmenopausal osteoporosis, demonstrating equivalent efficacy and safety to reference products in recent trials.

Trial Data Support Equivalence of Denosumab Biosimilar in Postmenopausal Osteoporosis

Biosimilar development costs could plummet from $100 million to $5 million, enabling smaller companies to enter the market and revolutionize access to essential medicines.

BioRationality: Entering a New Era of Affordable Biosimilar Development

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?

: If anyone is not familiar with the WHO Prequalification of medicines programmes, I would strongly encourage them to spend some time reviewing the resources and information on the Prequalification website as I am personally on the policy side of the Health Systems Division. In the space of collaboration, the Prequalification programme runs the Collaborative Registration Procedure (CRP) for medicines, vaccines and health products that have been prequalified by WHO. The CRP allows for participating regulators to request, with participation of the manufacturer, the reports and information that were submitted to WHO for regulation for use in considering national market authorizations.

In addition, the concept of regulatory reliance is also advancing through the use of a global benchmarking tool, where countries will be able to develop reliance schemes-based products manufactured under the supervision of recognized regulator. WHO also supports the implementation of WHO biosimilars guidelines in Member States. From November 26 to November 28 in Tunis, WHO will host an implementation workshop for regulators from Africa and the Eastern Mediterranean region, where experience and regulatory frameworks for biosimilars are still developing. This initiative is part of WHO’s ongoing work to promote harmonization and strengthen regulatory capacity globally.

How can we maintain industry sustainability if biosimilar medicines prices drop very quickly in multiple regions?

 Sustainability of the biosimilar business is linked to the overall functioning of the framework: there are many variables. Market competition is an inherent part of the follow-on medicines’ business. The starting points for all biosimilar medicines benefit is to have a multisource market where biosimilar medicines are used, and uptake is significant.


Are African CDC–equivalent agencies considering adding biosimilar medicines into pooled procurement mechanisms?

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