Bone Health

Immunology

Hematology

Respiratory

Dermatology

Diabetes

Gastroenterology

Neurology

Oncology

Ophthalmology

Rare Disease

Rheumatology

News

All News

Product Approvals and Launches

Media

All Videos

Insights

Interviews

Peer Exchange

Podcasts

Stakeholder Summit

Compendia

Conferences

Conference Coverage

Conference Listing

CME/CE

Resources

Authors

Biosimilar Resources

Interactive Tools

Partners

Polls and Quizzes

WHEN CHOICE ARRIVES: Competition & Consequences

Subscribe

BIOSIMILAR APPROVALS

Articles

Although financial incentives introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased.

Financial Incentives Boost Oncology Biosimilar Adoption, but Costs Remain Unchanged 

The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data 

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

BioRationality: A Proposal to Create a New Association With Rational Scientific Agenda

On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.

Can Global Policies to Boost Biosimilar Adoption Work in the US?

About

Editorial

Contact

Advisory Board

Do Not Sell My Information

Terms & Conditions

Privacy Policy

Center for Biosimilars®

Facebook

Twitter

LinkedIn

Business Practice

Business

Development

Legal

Policy

Practice

Regulatory

1rem

Business & Practice

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

FDA Approves Pavblu for Retinal Conditions

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

Expanding Biosimilar Adoption: Insights and Strategies With Dr Sophia Humphreys

The Future of Biosimilar Gene Therapies: Key Issues and Potential

IRA Reimbursement Impact on Biosimilars Minimal Despite Rising Market Share

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

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

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


Biosimilars Policy Roundup for September 2024—Podcast Edition

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

FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara

Ahzantive Receives FDA Approval as New Eylea Biosimilar

FDA Approves Epysqli as Second Soliris Biosimilar

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

Biosimilars and Employers: Strategies for Success

Learning the Lingo of Biologics and Biosimilars Is Critical

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

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

Biosimilars Policy Roundup for July 2024—Podcast Edition

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

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

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

To learn more about Cencora and their efforts, 

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

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








Biosimilars in America: Overcoming Barriers and Maximizing Impact

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

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

FDA Approves Henlius’ Trastuzumab Biosimilar, Hercessi

Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval

Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar

AON Saves Over $243 Million With High Biosimilar Adoption

Julie Reed: Why 2024 Is Important for Biosimilars

The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability

Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion

Review Highlights Most Popular European Policies to Boost Biosimilar Uptake

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

Biosimilars Policy Roundup for April 2024—Podcast Edition

As 2023 comes to a close, we look back on some of the major advancements from the past year, from the long-awaited market introduction of adalimumab biosimilars in the US, to the first major regulatory approvals for neurology biosimilars, to the implementation of key policy initiatives around the globe.

A lot of eyes have been on the United States and 2024 shapes up to be another big year for the biosimilar industry, with approvals for denosumab, aflibercept, and on-body pegfilgrastim biosimilars on the way. Additionally, the nation will continue to see the fallout from the implementation of the Inflation Reduction Act (IRA), including its policies regarding Medicare price negotiations, as well as the role interchangeability designations will play into adoption rates. It also remains to be seen whether payers and pharmacy benefit managers (PBMs) are ready to embrace newer biosimilars and add them to formularies as preferred products, leaving the future for a sustainable biosimilar industry up in the air.

Today, I'm joined by Brian Biehn, senior director of biosimilar commercialization, and Corey Ford, vice president of reimbursement and patient access, and policy insights at Cencora (formerly AmerisourceBergen). Both of them have been keeping a close watch on the biosimilar space throughout the year and today's discussion will surround how this year sets up a new chapter for the industry.

To learn more about the prospect for Neulasta OnPro biosimilars, 

To learn more about how the IRA will impact biosimilars, 

To learn more about the dual-pricing strategy being used for adalimumab biosimilars, 

To hear Brian's insight into how the ophthalmology biosimilar industry is developing, 

To listen to previous Not So Different episodes featuring more of Brian's insight into how the adalimumab market will develop and biosimilar pricing trends, 

On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.

A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond

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

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

To learn more about Tasmina's Asembia 2023 presentation, 

AmerisourceBergen Biosimilar pipeline report

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

Asembia

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

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

Although the oncology space is well-known for having the most successful biosimilar uptake, there are barriers that remain. Community oncologists and patients still have to reckon with pharmacy benefit manager (PBM) and payer formulary decisions, incentives for prescribing reference products, and inflated drug prices. However, community oncology practices have a unique opportunity to help boost biosimilar adoption and create savings for patients.

Today, I’m joined by Mark Guyot, senior director of unity provider engagement at McKesson, to discuss some best practices for biosimilar implementation in community oncology practices. Mark worked on creating and conducting McKesson’s real-world analysis that identified challenges and provided necessary support and education for successful biosimilar adoption. The analysis also led to changes within community oncology practices, resulting in significantly decreased care costs for patients, as well as annual cost savings to Medicare, totaling over $164 million.

To listen to our podcast with Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars, 

On this episode of Not So Different, Mark Guyot, senior director of unity provider engagement at McKesson, gives an overview of McKesson’s real-world analysis of community oncology practices and their use of biosimilars and offers advice on overcoming adoption barriers and expanding education efforts.

How Community Oncologists Can Break Down Biosimilar Adoption Barriers

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

On this episode of Not So Different, we recap some of the biosimilar policy news from the around the world during October, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.

Saskatchewan Becomes Sixth Canadian Province to Implement a Biosimilar Switching Policy

Advocacy Organization Calls for Ontario to Switch Patients to Biosimilars

BioRationality: a Dr Sarfaraz Niazi Column—The EMA Declares Biosimilars Interchangeable

Biden Authorizes Update to the Biosimilar User Fee Act Through 2027

New Bill Aims to Remove Barriers to Interchangeable Biosimilars

Amgen Report: Biosimilars Have Saved $21 Billion in 6 Years

It’ll Take a Village: Collaborative Efforts Needed to Increase Ophthalmology Biosimilar Uptake

Order of Operations: Managing Biosimilars While Maintaining Operational Efficiency

Dr Ryan Haumschild: What Health Systems Can Learn From Emory Healthcare's Biosimilar Strategy

Biosimilars Policy Roundup for October 2022—Podcast Edition

On this week’s episode, we’re discussing the stresses that practices and clinics face when trying to manage biosimilars as well as some policy considerations that administrators should keep in mind as more biosimilars enter the market and more payers add them to formularies.

I am joined by Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, and a member of The Center for Biosimilars® Advisory Board. She is an expert on the administration and practice perspective of managing biosimilars and has extensive experience supervising a practice that has had to adapt to the growing body of oncology biosimilars that have launched on the US market.

To read more of Kathy’s thoughts on the practice perspective regarding biosimilars, click 

To learn more about automatic substitution policies, click 

To learn more about some of the challenges clinicians could face next year as adalimumab biosimilars enter the market, click 

To learn more about prescription behaviors regarding biosimilars, click 

To listen to another podcast episode on a tool that can improve infusion center efficiency, click 

In this podcast episode, Kathy Oubre, MS, CEO of Pontchartrain Cancer Center, discussed the stresses that practices and clinics face when trying to manage biosimilars as well as some policy considerations that administrators should keep in mind as more biosimilars enter the market and are added to formularies.

Part 3 of this series for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.

Breaking Down Biosimilar Barriers: Interchangeability

Part 2 of this series for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.

Breaking Down Biosimilar Barriers: Payer and PBM Policies

Sophia Humphreys, PharmD, talks about biosimilars

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, explains that biosimilar adoption relies on clear strategies in the "buy and bill" medical benefit space. Successful integrated delivery networks (IDNs) collaborate with group purchasing organizations (GPOs) and 340B programs, regularly assess cost factors, and integrate biosimilar tools into electronic health records (EHRs) to simplify prescribing for physicians. Prior authorization processes for both biosimilars and reference products also streamline care. Regular performance reviews and sharing results with leadership help drive continuous improvement in biosimilar uptake.

First, Humphreys notes that we need to differentiate between medical benefit and pharmacy benefit. Many of the most successful biosimilars are in the medical benefit space, especially in the "buy and bill" space. IDNs that work closely with GPOs, 340B branches, and formulary management teams perform regular reviews of coverage, patient mix, and average sales price vs acquisition cost. These analyses help them decide which biosimilars to prioritize. 

Additionally, some IDNs have built biosimilar tools into their EHR systems to streamline physician workflows. Physicians are extremely busy and can’t be expected to remember which product to use each quarter, so it’s important to build support into the system. Some IDNs have also incorporated prior authorization processes for both the reference product and biosimilars, further streamlining care. Finally, it’s crucial to conduct regular performance reviews and share success metrics with leadership. This continuous improvement process elevates the entire system.

Videos

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses how integrated delivery networks (IDNs) can help drive biosimilar adoption.

How Strategic IDNs Boost Biosimilar Adoption

Sophia Humphreys talks

In an interview, Sophia Humphreys, PharmD, discusses how the expansion of biosimilars into new therapeutic areas, such as immunology, endocrinology, and ophthalmology, has led to increased hesitance compared to the quicker adoption seen in cancer treatment. This is due to the maintenance nature of many therapies, making it harder to switch patients to biosimilars. 

She emphasizes the need for patient and provider education about the safety, efficacy, and similarity of biosimilars. When addressing adalimumab biosimilars, Humphreys highlights factors such as product formulation preferences, interchangeability regulations, and payer coverage as key drivers in market competition.

This transcript has been edited for clarity.

How do new therapeutic classes and indications for biosimilars influence market expansion?

I think this goes beyond just patient education. And, for example, when we started with just the cancer curative and supportive agents, biosimilars, those are quickly adopted, and once we start to move into immunology, endocrinology and ophthalmology, now we started to observe more hesitance. 

One reason is because a lot of these are maintenance therapies. So we're not looking at starting a new treatment plan or starting a new cycle treatment with a new biosimilar. We're looking at convincing a patient who has failed several therapies before they reach the [reference] biologics now that could convince them to switch to a biosimilar product. So the first thing is that we really wanted to educate both our patients as well as our providers that these products are highly similar to the reference product. 

There's no evidence of diminished efficacy or increased immunogenicity or safety signals so far. For the past 10 years, we have used biosimilar successfully. And also we really wanted to address our health care system leaders that these biosimilar product in the expanded therapeutic classes would really increase access of care—really providing life saving, life altering medications for more patients.

What are the key factors driving competition among adalimumab biosimilars in the market?

Adalimumab, that's everybody's favorite molecule since July of 2023. So, several factors. This is actually quite similar—adalimumab and infliximab. It's almost similar. For autoimmune disease, as we have mentioned, a lot of patients are on maintenance [therapies]. And adalimumab has so many product [options]. And you really want to see if the product can match the existing product that our patient are using as much as possible. 

For example, if my patient is using a citrate-free product, you probably don't want to switch them to a product that is not citrate-free, which will cause probably more injection site discomfort. And also, a lot of patients prefer higher concentration vs lower concentration. That's another concern. And interchangeability is another concern. 

In a lot of states, we allow pharmacy-level switch, which means when a physician's order is the reference product for adalimumab in the state where they allow pharmacy-level switch, a pharmacist can switch the particular product to a interchangeable biosimilar of the reference adalimumab without a new authorization from the physician who prescribed that originator, because this particular product is interchangeable. 

Of course, different states have different regulations, and you also need to make sure that you meet the communication and information sharing requirement of your state, which means the patient needs to know that you're giving them a different product. The physician would need to know when you did the switching and which product was provided to the patient. Of course, most importantly, we need to know if the biosimilar you are switching to is covered by the patient's payers, and if they provide similar or comparable patient support and especially copay assistance. 

And when we are working with 340B-eligible sites, you would need to consider the switching effect to your 340B accumulation. So, a lot of factors are brought into this consideration. It's a very comprehensive analysis.

Sophia Humphreys, PharmD, from Sutter Health explains that expanding biosimilars into new therapeutic areas faces hesitance due to maintenance therapies, emphasizing the importance of education.

Addressing Hesitance in Biosimilar Adoption

Ha Kung Wong, JD 2

, brings a wealth of experience to the field of intellectual property law, specializing in patent and trade secret litigation. Beyond courtroom battles, his expertise extends to negotiating complex agreements for mergers, acquisitions, and collaborations across diverse industries, including pharmaceuticals, biologics, and cutting-edge fields like digital health and artificial intelligence. Wong's client roster boasts renowned names like Alkermes, Allergan, and the Bill & Melinda Gates Foundation.

 delved into Wong's insights in an interview on proposed patent law changes poised to significantly impact the biosimilars sector. These changes encompass limitations on asserted patents, the potential elimination of interchangeability requirements, and increased scrutiny of pharmacy benefit managers (PBMs).

Do you foresee any potential shifts or reforms in patent law that could positively or negatively impact the biosimilars sector in the near future?

Predicting whether there will be statutory shifts or reform in patent law is like trying to predict what will happen in the next 

 movie—you have no idea what specifically is going to happen but it's probably going to have some explosions that ultimately, will not be applicable to the real world. That being said, there are a few things I think that we might want to keep an eye on. I say "very few" only because we've seen a lot of things introduced and not a lot of follow through. There's a lot of good intentions out there, but there's not a lot of follow through. That being said, here it is.

First of all, Senators [Peter] Welch [D, Vermont], [Mike] Braun [R, Indiana], and [Amy] Klobuchar [D, Minnesota] introduced legislation in the Senate, and Representative [Jodey] Arrington [R, Texas] in the House on January 2024 that would limit the number of patents that could be asserted in a patent litigation. If this were to proceed, this may or may not have a practical effect because we've seen that most Bundled Payments for Care Improvement 

lawsuits that have been asserted are asserted on 10 or less patents. So, having an artificial limit may not make it any better. But it might. Who knows? It is certainly something to keep an eye on.

The Biosimilar Red Tape Elimination Act was introduced in July 2023 by Senators [Mike] Lee [R, Utah], [Ben Ray] Lujân [D, New Mexico], Braun, and [J.D.] Vance [R, Ohio]. That bill would eliminate the 2 separate designations of biosimilars and interchangables, which we know, exist in the US and we are the only country that does that. Every other country in the world only has 1 level of biosimilarity. It's possible if the interchangability requirement was removed, there could be greater uptake of biosimilars due to the possibility of automatic substitution at the pharmacy level, like we see with generic drugs. There may be increased confidence in biosimilars because they would be seen as perhaps closer to the reference product.

Ha Kung Wong, JD, examines proposed patent law changes that could significantly impact the biosimilars sector, including limitations on asserted patents, elimination of interchangeability requirements, and heightened oversight of pharmacy benefit managers.



Policy

Latest News