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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

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

This episode of Not So Different explores the possible implications of the Federal Trade Commission's (FTC) second interim report on pharmacy benefit managers (PBMs), which shed light on key issues with current PBM practices and their impact on drug prices. The report highlighted several troubling strategies, such as many cases where the big 3 PBMs were reimbursing their own affiliated pharmacies at higher rates than independent pharmacies. The report's latest findings raise important questions about the future of drug pricing transparency and regulation and challenge the notion of whether PBMs are delivering on their intended promise to benefit the health care system.

To help unpack these findings and their implications, The Center for Biosimilars

 was joined by Joe Wisniewski, an expert in PBM legislation, price transparency, and health care policy. Joe serves as assistant vice president of partnerships and government affairs at Turquoise Health and brings a wealth of insight into how PBMs are navigating the current landscape, especially with the rise of new biosimilars and shifting regulatory pressures.

This episode also explores how a second Trump administration could influence PBM practices, particularly in relation to biosimilars, and what that means for drug pricing efforts moving forward.

To learn more about the FTC's most recent report on PBMs, 

To learn more about the FTC's first report on PBMs, 

To learn more about health care actions taken by the second Trump Administration during it's first month, 

To learn more about the views of Mehmet Oz, MD (more commonly known as Dr. Oz) on price transparency ahead of his congressional confirmation hearings as President Trump's nominee for HHS Secretary, 

On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.

Will the FTC Be More PBM-Friendly Under a Second Trump Administration?

On 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

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

To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.

President Trump Signs Executive Order to Bring Down Drug Prices

States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.

How State Substitution Laws Shape Insulin Biosimilar Adoption

Elie Bahou talks IDNs and biosimilars 1

In an interview, Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, outlined key barriers to biosimilar adoption within integrated delivery networks (IDNs) and strategies to overcome them. He highlighted provider apprehension and operational hurdles, such as electronic medical record challenges, as significant obstacles.

Bahou also emphasized the importance of strategic payer collaborations, flexible contract terms, and patient and provider education to enhance access to high-cost biologics, reduce disparities, and improve adherence through clear communication of treatment benefits and outcomes.

This transcript has been lightly edited for clarity.

What are the specific barriers to biosimilar adoption within IDNs, and how can IDNs incentivize physicians and pharmacists to prescribe biosimilars over originator biologics?

That's a good question. Doctors typically memorize 10 to 12 medications they're comfortable with. They like to prescribe them over and over. They have the names, they know the side effects, etc. So it's hard to break habits with doctors, as you can imagine. So I would say that provider apprehension or doctor/physician apprehension is there, and we need to educate them on the obstacles of implementing and switching, and the positive aspects of switching. The fact that they're similar drugs called biosimilars, and they save us sometimes 60% of the actual price [of the originator]. And then operational or technical barriers are also some of the challenges with respect to our EMR (electronic medical record) called Epic. 

Even though a doctor prescribes a drug, if the payer, meaning the PBM (pharmacy benefit management) company, does not have that drug biologic on the formulary, they won't pay for it. So that's another complication. How do we mitigate that? We just engage the providers, as I said, to get them comfortable and make them understand the importance of these biologics. We work with the organizational P&T [pharmacy and therapeutics] committee to facilitate adoption of these biologics and to help guide [providers] on prescribing them. 

Then, we use our clinical informatics team to ensure a seamless adoption of these biosimilars, and then we work closely with the manufacturers that make these biologics to bring additional value through contracting. So, those 4 ways are how we mitigate that.

What changes in pharmacy benefit design could lead to a more equitable balance between patient cost-sharing and access to high-cost biologic medications?

Good question. I think one of the best ways to do it is to just develop strategic partnerships with these drug manufacturers by negotiating pricing based on volume purchases, which is what they want, and on outcome. So that includes flexible type of contract terms that allows us to revisit the value and the volume more often to adjust according to market dynamics and payer coverage and then [we have more input with] engagement and policymakers and professional organization for policy type of advocacy. 

So we have a whole government affairs team that really works very hard and lawyers and advocates that work in Washington, DC, to help us with that. And then, provider education—educate the health care providers in our system on the latest evidence-based type of practices to help them pick which biological that's more cost-effective to use for the best optimal outcomes. That's pretty much it. We educate our patients. We make sure that they are aware and understand what the therapy is used for, including potential benefits as well as side effects to enhance their adherence to their medication and their willingness to take it. That's pretty much it in a nutshell.

Videos

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discussed barriers to biosimilar adoption and highlighted strategies such as physician education, streamlined implementation, payer collaboration, and patient engagement to improve access, reduce costs, and enhance adherence to biologic therapies.

Strategies for Improving Biosimilar Access and Utilization

steve pickette talking about biosimilars and AI

Steve Pickette, PharmD, BCPS, chief clinical pharmacist at InpharmD, highlighted the transformative role of artificial intelligence (AI) in managing biosimilars and generics. He explains that AI can significantly reduce the workload for clinical and pharmacy staff by streamlining the analysis required for prescribing and formulary changes, enabling better engagement with health care providers. Additionally, AI enhances pharmacovigilance by monitoring formulary changes, tracking adoption rates among providers, and identifying potential issues.

How can AI help with the prescribing of biosimilars and generics and, can it aid in pharmacovigilance of these products?

Yes, it can aid in prescribing, in reducing the overhead burden of doing the analysis and free up the pharmacy drug information services or clinical staff to engage with the providers. And change management is always a big part of the formulary process—really the most challenging part and it seems like we never have the time to do it. And you get the analysis together as part of the P&T [Pharmacy and Therapeutics Committee], and you get it out there for the doctors, but I rarely would have the time to really engage them and go over it and look at it. So, it really aids in the process in that way.

And then you mentioned the vigilance of seeing how things have gone. That is another area where we never seem to have time. You do a formulary interchange, you've gone through the whole process, you've made the change, and you move to a different product, and then you move on to the next evaluation. And so it's always a kind of a stressor in the back of our minds for those of us that manage formularies. Is it still going okay? Has something changed? I think that's a big benefit of the use of AI-assisted analytic tools, such as what we've built, is it will track and alert you if something has changed or tell you that it's doing well and let you know how things are going. For example, there's a certain set of providers that aren't adopting it. That's another medication use evaluation process that's really challenging, labor-intensive, and time-consuming. So, [this technology] is really promising in all those regards.

Steve Pickette, PharmD, BCPS, emphasizes that AI can streamline prescribing and formulary management for biosimilars and generics, enhance provider engagement, and improve pharmacovigilance by tracking adoption rates and identifying potential issues.

AI-Powered Solutions for Streamlining Biosimilar Prescribing and Monitoring

global biosimilars week webinar

 was hosted by The Center for Biosimilars

 in partnership with the International Generics and Biosimilars Association.

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

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

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



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

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