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WHEN CHOICE ARRIVES: Competition & Consequences

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Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, explain the misconception that cheaper biosimilars automatically lead to lower costs due to pharmacy benefit manager (PBM) spread pricing, while also highlighting major PBM trends toward increased transparency, value-based care, and efforts to reduce prescription costs.

Biosimilar Misconceptions, PBM Transparency, and Value-Based Care: Insights from Canavan & O'Dell

Articles

Patients with inflammatory bowel disease (IBD) show high acceptance of adalimumab biosimilars, achieving positive outcomes and clinical remission after switching.

High Acceptance Levels After Switching to an Adalimumab Biosimilar for IBD

Here are the top 5 biosimilar articles for the week of June 9, 2025.

The Top 5 Biosimilar Articles for the Week of June 9

Switching from reference ustekinumab to biosimilar FYB202 maintained comparable efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.

Biosimilar FYB202 Shows Therapeutic Equivalence to Ustekinumab for Plaque Psoriasis

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

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Clinical

Application of Recent Data in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema: Managed Care Insights and Strategies

Leveraging Novel Therapies to Transform Demodex Blepharitis Care

Patient-Centered Treatment Plans for Management of Neovascular (Wet) AMD and Diabetic Macular Edema: Insights on Recent Efficacy, Safety, and Real-World Data to Improve Adherence and Outcomes

Leveraging Novel Therapies to Transform Demodex Blepharitis Care (6/11)

Integrating Multi-Cancer Early Detection Tests Into Clinical Practice: The Health Economics Perspective for Managed Care Professionals

1.5 Credits / Endocrinology, Diabetes & Metabolism, Ophthalmology/Optometry

The Evolving Strategies for Managing nAMD and DME: Empowering Managed Care Decisions for Improved Patient Outcomes

Welcome to another insightful episode of Not So Different: a Podcast from The Center for Biosimilars. In this episode, we bring you detailed coverage of the trends, challenges, and insights gathered from the Festival of Biologics USA. 

Your host, Skylar Jeremias, assistant managing editor of The Center for Biosimilars

, and guest Dracey Poore, director of biosimilars at Cardinal Health, delve into the crucial themes that emerged from the conference discussions, mainly, the essential role of sustainability in the biosimilar industry. You'll hear about the forward thinking vision of the biopharmaceutical sector, as they maneuver through the evolving biosimilar landscape in their quest to make critical medications accessible to patients.

The conversation travels deeper into the biosimilar ecosystem as Poore explains the effect of significant challenges obstructing the widespread adoption and affordability of biosimilars. 

With insights from the richly detailed Cardinal Health Biosimilar Report, Jeremias and Poore guide you through the evolving prescriber trends and insights that influence biosimilar adoption alongside constructive strategies to overcome these hurdles. This episode sheds light on the importance of ongoing education, dismantling access barriers and promoting a competitive biosimilar market for a better health care landscape.

To read our coverage of the Cardinal Health report, 

To check out The Center for Biosimilars coverage of Festival of Biologics USA, 

00:03:48: Discussion on Cardinal Health Biosimilar Report and challenges to biosimilar adoption

00:04:48: Best practices for managing biosimilar inventories

00:08:05: Legislative efforts impacting the biosimilar landscape

00:10:38: Impact of payer preferences for reference products over biosimilars

00:13:36: Concluding thoughts on the future of biosimilars

Cardinal Health

The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.

Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report

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

2023 is gearing up to be a big year for biosimilars, especially in the United States, where up to 10 adalimumab biosimilars referencing Humira, one of the most expensive drugs in the world, will enter the market. In addition to that, we will see the fallout of major government policies, such as the Inflation Reduction Act and the Biosimilars User Fee Amendment, as well as how the market will respond to so many biosimilars entering the market at the same time. How will the first 6 months go? How will payers and pharmacy benefit managers (PBMs) alter their coverage options? Will interchangeability designations make a difference? Will biosimilars be able to get a greater piece of the market pie?

On this episode, Brian Biehn, senior director of biosimilar commercialization at AmerisourceBergen, explored how the new year may play out for biosimilars, including his predictions or how uptake will be influenced in the adalimumab market and how government policies will impact the competitiveness of the market.

To read more about adalimumab biosimilars, 

To read more about ophthalmology biosimilars, 

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

To read more about the reauthorization of the Biosimilars User Fee Amendment, 

New Year, New Hurdles: What's in Store for Biosimilars in 2023

On this episode of Not So Different, we spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, to discuss the US launch of Byooviz, the first ophthalmology biosimilar and the first biosimilar referencing Lucentis (ranbizumab) in the United States. We also talked about how this launch is expected to impact ophthalmology care going forward and what needs to be done to ensure patients have adequate access to this biosimilar and other ophthalmology biosimilars in the future.

To learn more about the US launch of Byooviz, click 

To read more about the anticipation for ophthalmology biosimilars, click 

To read more of Dr. Oskouei’s comments on “Round 2,” click 

To learn more about the EU approval of Byooviz, click 

To learn more about the Canadian approval of Byooviz, click 

To read more on the anticipation for aflibercept biosimilars, click 

On this episode of Not So Different, we spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars at Cardinal Health, to discuss the US launch of Byooviz, the first ophthalmology biosimilar in the United States, and how it's expected to impact ophthalmology care.

New Biosim on the Block: Dr Sonia Oskouei Discusses the US Launch of Byooviz, the First Ophthalmology Biosimilar

Recently, one of our Advisory Board members, Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, wrote an opinion piece on the status of ophthalmology medications and the potential for ophthalmology biosimilars. We spoke with her to learn more about this topic and her opinions on what needs to be done to accelerate biosimilar use in this growing therapeutic area.

To read more on Dr. Oskouei's contributor piece, click 

To learn more about Cardinal Health, click 

We spoke with Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, about the status of ophthalmology biosimilars and her opinions on what needs to be accomplished for these agents to flourish.

Not So Different: Why You Should Keep Your Eye on Ophthalmology Biosimilars

Cimerli offers a promising biosimilar treatment for age-related macular degeneration, enhancing vision preservation with its effective vascular endothelial growth factor inhibition.

Cimerli Offers a New, Interchangeable Biosimilar for Ocular Conditions

Eye on Pharma: Interchangeability, Private Labels, and Patent Settlements for Biosimilars

The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.

Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD

Patients with diabetic macular edema previously treated with a ranibizumab biosimilar in India experience comparable safety and efficacy after being switched to another ranibizumab biosimilar, demonstrating real-world safety of biosimilar-to-biosimilar switching.

Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

EC Approves Celltrion Denosumab, Aflibercept Biosimilars

Brian Biehn from Cencora makes predictions for the US biosimilar market based on recent FDA approvals

Cencora's Brian Biehn Forecasts Big Changes for the US Biosimilar Space

Brian Biehn, senior director of biosimilar commercialization at Cencora, formerly known as AmerisourceBergen, recaps some of the major regulatory updates for biosimilars in the United States and makes predictions for how the market will develop in the years to come.

2023 was a big year for biosimilars in the US, with the market introductions of 8 adalimumab biosimilars as well as regulatory approvals for the first biosimilar tocilizumab, nataliuzmab, and subcutaneous infliximab. How do you think these advancements will shape the biosimilar market in the coming years?

Yeah, 2023 was definitely a big year for biosimilars. As you mentioned, we continue to have really good momentum with approvals. The approvals are written into new molecules such as tocilizumab and natalizumab. The approval for natalizumab [marks] the first neurological biosimilar, which is expected to hit the market in 2024. All eyes are still on adalimumab, though, and the Humira biosimilars.

So, today we have 9 manufacturers that have [approvals and 8 launches for] biosimilars to Humira [reference adalimumab]. There are still a few in the pipeline. We do believe the success of the future market is going to be shaped by the Humira market, specifically for the pharmacy benefit space [overall] and those biosimilars to come. So they're all kind of looking at Humira and seeing how are those manufacturers going to do? How successful are they going to be? What is the adoption going to look like?

To date, we've seen slow uptake of those Humira biosimilars, but we are expecting that to become more widespread going into 2024 and 2025. We believe there's kind of a period here where [pharmacy benefit managers] and payers need to become comfortable with the Humira products; they need to put them on the formulary. Also, from a downstream perspective, customers and patients need to become more comfortable with these products. So, even though it's been a slow start for Humira [biosimilars] and that's probably the biggest thing that happened in 2023 with those [launches], we do see some upside and are expecting more adoption to occur in the coming years.

Now that ophthalmology biosimilars have been on the market for a year and both FDA-approved products now have interchangeability, what is the current status of ophthalmology biosimilars and how to do you see this changing going forward?

Ophthalmology biosimilars are doing well. We've seen month over month the adoption continues to increase. We do anticipate that this trend is going to continue as there are still more manufacturers in the pipeline, specifically for the Lucentis [ranibizumab] biosimilars, which already have the 2 biosimilars on the market.

We're also really interested to see where the Eylea [aflibercept] market goes. We're expecting, potentially in 2024, biosimilars will start to move in that market. We have some ongoing patent litigation occurring right now that could push that launch back to later, but the most optimistic right now is potentially 2024.

One of the things that we continue to talk about with ophthalmology biosimilars—we've talked about in the past and it's important to most of the biosimilar market categories, but more specifically this one—is education. We've heard that there has been confusion amongst providers and patients with these products, not being aware that they're available, being a little bit hesitant to use them because it is an injection into the eye. So, education still remains to be the largest barrier. We have seen that education gap tighten. As I've said, the adoption has increased over time, but I still think it's important for us as an industry to keep pushing that education forward and trying to combat any misinformation that's going on and drive awareness of these products.

Brian Biehn, senior director of biosimilar commercialization at Cencora, makes predictions for how big regulatory approvals in 2023 will shape the biosimilar space going forward.

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, and Sneha Sharma, PharmD, director of specialty clinical solutions at Magellan Rx Management discuss some of the major topics of concerns surrounding the use of ophthalmology biosimilars.

So far, there are 2 ophthalmology biosimilars on the US market, both of which are ranibizumab products and vascular endothelial growth factor inhibitors (anti-VEGF). Biosimilars for ophthalic indications are new globally and the biggest challenge facing this sector of the industry is how to get patients and providers to trust that biosimilars are as safe and effective as their originators.

This interview is part 3 of a multimedia series on ophthalmology biosimiars in the United States expanding on the discussion from our LinkedIn Live event “

In Sight: The Future of Biosimilars in Ophthalmology Care

, a written Q&A Kyung-Ah Kim, executive vice president of Samsung Bioepis. Click here for 

, a podcast episode of Not So Different featuring Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars.

How have payers responded to the influx of ophthalmology biosimilars so far and are they preferring interchangeable biosimilars?

The ophthalmology biosimilars came onto the market late last year. So the influx has been dependent on a few factors [and] we haven't seen much uptake yet. Avastin [reference bevacizumab] is the most cost-effective product in this category. So there's still some uncertainty as to how the biosimilars will be preferenced in this category.

Some experts are concerned about anti-VEGF biosimilars having an interchangeability designation because the label does not impact biosimilars dispensed through the medical benefit, potentially causing confusion over what the label means. How do payers view interchangeability generally and how will these views shape the biosimilars space?

Yeah, I feel the interchangeability designation certainly allows for better access to biosimilars. Especially with the automatic substitution piece, I feel that the payers are thinking ahead of the game in thinking these might be easier to preference, because they have that automatic substitution piece, especially in the pharmacy benefit, where they won't really need a new prescription to substitute an interchangeable biosimilar for a reference product. So definitely has some impacts there.

For the medical benefit, I feel like the impacts are still unknown because Cimerli [reference ranibizumab] just came out as the first medical benefit interchangeable biosimilar. All the other ones were on the pharmacy side. So the impacts for medical benefit are unknown, but I feel like this will only create more flexibility and confidence in the provider community to prescribe biosimilars for this category.

So far, ophthalmologists are very concerned about the safety of ophthalmology biosimilars, particularly because all the FDA-approved ophthalmology biosimilars so far are administered via an injection in the eye. How might payer preferences for ophthalmology biosimilars impact physician confidence in these products?

Sure, it's a valid concern—you are injecting a drug into the eye. But the reference product for these ophthalmology biosimilars has little to minimal interocular inflammation or adverse events. So, a biosimilar should behave similar to their reference product. As we've seen in other categories where biosimilars have been introduced, they've been used safely and efficaciously. And our clients, payers, health plans, [almost] everyone is pretty much familiar with step therapy, so providers should be familiar with that if preferencing does occur for the biosimilars.

The FDA has said that it granted Cimerli, a ranibizumab biosimilar, interchangeability without a switching study data because the company asked for it and because the administration route did not require additional testing. How do you think this decision will impact the overall view of interchangeability designations and the safety of ranibizumab biosimilars?

Right, you're correct. The second ranibizumab biosimilar, which is Cimerli, did get an interchangeable designation without a switching study. Now, when we look at the data, [the manufacturer] did supply strong clinical data and robust analytical data, which led the FDA to believe that there is no risk in switching between the biosimilar and the reference product. And that is why they granted this approval. So, in my opinion—having that approval in place [without] having like the switching study—if there is strong data as compared to switching study and as long as there is no risk for FDA, that approval is okay and should not really create any confusion in terms of interchangeability.

How do you think the Inflation Reduction Act [IRA] will impact the accessibility and affordability of biosimilars?

The IRA is still very, very new and all of us in the managed care community are trying to find out what is going to be the impact with biosimilars. So one thing that comes to mind is that some of the select biosimilars are going to have a little bit of extra payment from Medicare, and that is going to be temporary for 5 years, but still it is an incentive. So, I feel like that particular thing will certainly boost the biosimilar prescribing and make biosimilars more flexible since Medicare is going to be raising a little bit of payment rates on them.

Usually, when the United States is introduced to biosimilars in a new disease state, it can look to the European Union’s real-world evidence to boost physician and patient confidence. However, the ophthalmology biosimilar space is very new globally. How do you respond to ophthalmologists, payers, and patients when they express concerns over the lack of real-world data?

As with anything, education and experience are the best teachers and there is lack of real-world data. But at the same time, as I mentioned, we've seen biosimilars be used safely and efficaciously in other disease states. And we do have safeguards in the US. If there are adverse events that need to be reported, the FDA does intervene. But we should expect the biosimilars to behave similarly and the studies that have been conducted are also a standard in the US, so we shouldn't see any issues.

What actions can clinics take to better advocate for ophthalmology biosimilars and instill greater confidence in the safety of these products?

Sure, so clinics can educate the patients and the staff on what studies have been conducted, how biosimilars have been safely used in other disease states, intervene with pharmacist Lunch and Learn education. Again, education is key. And you can arm yourself by being comfortable with using the products, similar to how Avastin came about in this market [and] other drugs. We [originally] weren't sure how they would behave post market. So there is a lot of opportunity to just educate the patient.

Prerakkumar Parikh, PharmD, and Sneha Sharma, PharmD, from Magellan Rx Management, tackle some of the biggest concerns ophthalmologists have regarding emerging biosimilars for ophthalmic conditions, including interchangeability as well as lack of real-world evidence and education.

Part 3: Drs Sneha Sharma and Prerakkumar Parikh Quell Concerns About Ophthalmology Biosimilars

Unless pharmacy benefit managers (PBMs) stepping up to support biosimilars and provide broad access to these lower-cost products, the promised savings from ranibizumab and adalimumab biosimilars are going to develop slowly and a healthy competitive marketplace will be in jeopardy, said Juliana (Julie) Reed, executive director of the Biosimilars Forum, in an interview from Asembia 2023.

Although anticipated savings related to adalimumab and ranibizumab biosimilars are expected to develop over a long period of time, how long do you think the US will have to wait to see big price changes, and what needs to happen to ensure ample competition between products?

So I think that we could see immediate savings if the PBMs [pharmacy benefit managers] changed their model—they embrace biosimilars, they embrace competition, and they moved towards providing that and providing access. Otherwise, the savings will be slow. And it's not because [the Forum's] members did not develop or take all this time. If we have [9] biosimilars to Humira [adalimumab] is launching at 10 years of development, that's [90] years of development, and over $2 billion spent. And that's the concern—that all this time, these years, and all this money but PBMs won't provide access, and I mean preferred access. They need to support the industry. They need to support the competition. 

IQVIA and other economists have said that we could see close to $155 billion in savings by 2025. That's 2 years from now and that has a lot to do with those biosimilars launching. Those are real numbers and there's concern that those savings will not be realized. And I think the question will be why? Because we certainly we developed the biosimilars and we're bringing them to the marketplace, and we know they're safe and efficacious and approved by the FDA. So if we don't achieve those savings, the question is why, and we know that it's because we don't have access to the market and we're not able to compete.

Juliana (Julie) Reed, executive director of the Biosimilars Forum, predicts how long it will take for savings from adalimumab and ranibizumab biosimilar competition to fully manifest and how stakeholders can champion for better market competition for biosimilars.

Conference

Julie Reed: When the US Could See Meaningful Savings From Adalimumab, Ranibizumab Biosimilar Competition

Hi, I’m Justina Petrullo for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of May 1st, 2023.

Number 5: Samsung Bioepis shared positive 1-year results from a phase 3 trial 

 between the company’s aflibercept biosimilar and the originator (Eylea) at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting.

Number 4: In April, biosimilars to treat rheumatic conditions had some progress, as well as some setbacks, and 

 that switching from originators to biosimilars is safe and effective but warned about the nocebo effect.

, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Number 2: Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar 

 responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.

Number 1: Sarfaraz K. Niazi, PhD, dove into 

 may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of May 1, 2023. 

The Top 5 Biosimilar Articles for the Week of May 1

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, recapped the launch of Biogen's and Samsung Bioepis's ranibizumab biosimilar as well as how leveraging campaigns like the International Generic and Biosimilar Medicines Association's Global Biosimilars Week can help boost biosimilar adoption rates.

Biogen and Samsung Bioepis had a big year with the launch of Byooviz, the first ophthalmology biosimilar and the first ranibizumab biosimilar to enter the US market. What has been your initial experience with this launch and how do you expect this market will play out in 2023?

So, from the voice of the customer, we've heard excitement about Byooviz approval and launch into the marketplace. The ophthalmology market in this area, [Medicare] Part B in the US, is probably characterized by a lot of private equity groups that run ophthalmology clinics. Plus, there's a group of new operators that are operating in retinal specialist centers with maybe 1 or 2 physicians. And so you get 2 different aspects of the business. 

From that perspective, it's been well received. In terms of insurance coverage, again, insurance coverage is being positive in terms of speed to getting that coverage applied. And then, I think in terms of the programs that we've got in place, like patient services, etc, it's been an overall positive response.

Why are companies like Biogen so focused on investing in biosimilar development, especially in newer markets, such as ophthalmology and rheumatology?

Firstly, when people look at biosimilars from a company perspective, they're looking at it from an opportunity for revenue or to facilitate efficiencies around production or to deploy their technical knowhow, particularly in biotech. So, what you get is a number of different synergies. But on top of that, if you think about how we are relieving costs out of [Medicare] Part D or Part B, and then you're also putting new products into these areas, it has a very sort of balanced response with payers and providers of care in these areas. So, that's number one. What you're providing is savings and an opportunity for those savings to be used, either in new innovations or improving patient access. 

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, describes the importance of awareness campaigns like the International Generic and Biosimilar Medicines Association's Global Biosimilars Week and how these initiatives can be leveraged to improve biosimilar adoption and acceptance.

Ophthalmology

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