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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

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.

Articles

BioRationality: No More Clinical Efficacy Testing for Biosimilars, Going From Biosimilars to Biogenerics

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

HLX02 shows promise as a safe, effective trastuzumab biosimilar for HER2-positive metastatic breast cancer, enhancing treatment access and affordability.

Real-World Evidence Supports Biosimilar HLX02 in Metastatic Breast Cancer

Laura is the editorial director of The American Journal of Managed Care

) and all its brands, including The American Journal of Accountable Care

, Evidence-Based Oncology™, and The Center for Biosimilars

, since 2011. She has an MA in business and economic reporting from New York University.

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market.

Australian Study Reveals Significant Cost Savings and Market Impact From Biosimilars

A study reveals that switching from Humira to Amgevita for IBD maintains disease control and offers significant cost savings.

Switch to Biosimilar Adalimumab Found Safe and Cost-Saving for Patients With IBD

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

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Business & Practice

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

Escaping the Void: All Things Biosimilars With Craig & G

Co-hosts Craig Burton, executive director of the Biosimilars Council, and Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

 was developed in partnership with the AAM and Biosimilars Council.

By Ashley Henyan, MA, MFA, director of communications at AAM

Since the passing of the Biologics Price Competition and Innovation Act in 2010, the FDA has approved over 70 biosimilar medicines. Since their entry to market in 2015, biosimilars have generated $36 billion in savings for America's patients and the US health care system. Biosimilars have proven they can unlock access to safe, effective, and more affordable treatments. But unfortunately, a dangerous trend threatens to halt progress related to biosimilar uptake and patient access. 

In February 2025, an analysis from the IQVIA Institute revealed a massive biosimilar void.

 A staggering 90% of biologic drugs losing patent exclusivity over the next 10 years have no biosimilar competition in the pipeline. This data underscores a flawed system that limits patient access and negatively impacts the livelihood of millions of Americans. 

However, when it comes to biosimilars, we have the tools to fix the problem. With the right focus, collaboration, and reforms, we can ensure biosimilars continue to bring value to patients, providers, and the broader health care system. 

With thanks to The Center for Biosimilars, this podcast series explores the current biosimilars landscape, dives into urgent actions needed from policymakers and regulators, and offers real-world insights into what changes are needed now to ensure the sustainability of the industry. 

1. Jeremias S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. February 5, 2025. Accessed May 3, 2025. 

To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

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

New denosumab biosimilars, Bildyos and Bilprevda, enhance access to affordable osteoporosis and bone disease treatments, promising significant patient benefits.

FDA Greenlights Fifth Pair of Denosumab Biosimilars: Bildyos and Bilprevda

Canadian study reveals no significant differences in remission outcomes between etanercept biosimilars and the originator, Enbrel, for rheumatoid arthritis patients.

Canadian RWE Shows Comparable Outcomes Between Etanercept Biosimilars, Originator

Patent thickets hinder biosimilar access, driving up costs and delaying affordable treatments. Discover legislative solutions to enhance competition and patient care.

Clearing the Thicket: New Report Outlines Legislative Fixes to Boost Biosimilar Access

Overcoming Patient Education Gaps, Biosimilar Financial Hurdles in Focus With Canavan & O’Dell

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, and Chris O'Dell, senior vice president of market solutions at Turquoise Health, discuss how the health care system must overcome patient education gaps and address perverse financial incentives within contract structures that currently favor higher priced reference products in an interview with The Center for Biosimilars

Canavan highlights patient and provider education as the primary challenge and opportunity. He emphasizes pharmacists' crucial role in educating patients about biosimilars, navigating prior authorizations, and providing essential feedback to address barriers.


O'Dell focuses on perverse financial incentives within the current market structure as a significant impediment. He explains that contract structures, particularly those where entities profit from higher drug prices, discourage biosimilar adoption. 

This transcript was lightly edited for clarity; narration and captions were generated by AI.

The adoption of biosimilars within the health care system faces significant challenges. These include overcoming gaps in patient and provider understanding, as well as addressing existing financial structures that may inadvertently favor more expensive reference products.

From your perspective, what are the most significant factors influencing the adoption of biosimilars in the current health care landscape, and where do you see the greatest opportunities or challenges for improving their uptake?

It's education. The recurring theme here is education, and pharmacists are a huge touch point with patients at the pharmacy counter. One of the things that being a pharmacist helps with is acknowledging that the patient may have some issues with this. It may be a different medication than they're used to taking. They may not even know what a biosimilar is, and trying to talk about that before explaining what it is, or having any baseline education around that, is a problem. The pharmacist really alleviating some of those issues that the patient may have is going to be huge with biosimilars.

Another thing we see is prior authorizations. Even with biosimilars, sometimes those require prior authorizations from the PBM. It is explaining to the patient why that's taking place, why it's happening, even with the biosimilar, making sure that they know they will be able to get their medication, even if there is a slight delay in it.

Also, pharmacists are great with the feedback loop. When we talk to pharmacists at Razor, we ask a lot of questions about what they're seeing at the pharmacy, how things are working, and problems they're facing. They relay those to us, and then we can help break down those barriers again, helping the patient get the medication. There's a lot of empathy there with pharmacists. They want the patient to have the medication as soon as possible. We want the same thing. How can we work together with that feedback loop to make sure that happens?

Let's take 2 different contract structures, one that is paying you some markup on the drug and one that is paying you at a set fee schedule. In one system's case, or in one PBM's case, the system actually makes more when you increase the price of the product. In the other one, the end system, let's call this the payer in this example, actually has to pay less when they decrease the price of the product.


When you look at a reference price, you have to say by dropping ASP [average sales price] way, way, way, way down, so you've rebated the system heavily, tried to promote "Hey, I will give you the kitchen sink if you just use my biosimilar relative to the other product". If they don't make more money on that, meaning you drive the ASP down, and they're getting paid at some variation of ASP, then it's all for naught. The market's not working well because as the price goes down, the end entity who's prescribing it is making less and less margin than they were on the reference product.


That has probably hindered adoption of biosimilars relative to what we would expect because if it were cheaper and just as clinically efficacious, meaning that the patient got it for cheaper, the payer paid less, and the manufacturer could still make a margin on it, then we would see much broader adoption. I think there are a lot of perverse incentives, things like rebates, maybe when you get paid relative to the sticker price, which is WAC [wholesale acquisition cost], then your margins are much better, that have allowed the reference product to stay bolstered and commonly used relative to the biosimilar.

Videos

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, explain that widespread biosimilar adoption requires addressing patient and provider education gaps through pharmacists and rectifying perverse financial incentives within health care contract structures. 

Expert Insights on Overcoming Patient Education Gaps, Biosimilar Financial Hurdles

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.

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?

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.

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