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WHEN CHOICE ARRIVES: Competition & Consequences

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Cameron Santoro is an associate editor for The Center for Biosimilars

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Here are the top 5 biosimilar articles for the week of March 24, 2025. 

The Top 5 Biosimilar Articles for the Week of March 24

Articles

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.

FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra 

Pharmacists play an essential role in counseling patients on biosimilar substitution protocols and following state regulations regarding interchangeable medications.

As Biosimilar Substitutions Become More Common, Education and Patient Counseling Are Paramount

Switching between adalimumab products does not affect drug effectiveness or treatment duration in patients who have psoriasis, according to a Danish study.

Adalimumab Biosimilars Show Similar Outcomes in Psoriasis After Nonmedical Switch

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People with Crohn disease (CD) or ulcerative colitis (UC) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.

 (ReFLECT) investigated treatment persistence with the infliximab biosimilar CT-P13 (Inflectra) in patients with inflammatory bowel disease (IBD) who were either infliximab-naive or were switching from the reference product (Remicade) or biosimilar SB2. Overall, treatment persistence was 72% in patients with Crohn disease and 64% in ulcerative colitis at 2 years, and the rate of persistence was higher in switched patients compared to infliximab-naive patients. No new safety signals were observed.

CT-P13 was the first biosimilar monoclonal antibody approved by the European Medicines Agency in 2013, and the first biosimilar to Remicade, an inhibitor of tumor necrosis factor (TNF)- α. Its approval in Europe and extrapolation to all the indications of the reference product were based on randomized controlled trials in patients with rheumatoid arthritis and ankylosing spondylitis. More recently, large randomized controlled trials have established efficacy and safety of switching to CT-P13 from the originator in IBD. Although the safety and efficacy of CT-P13 has been demonstrated by these randomized controlled trials, the authors said, few real-world studies have reported CT-P13 persistence in IBD with follow-up duration longer than 1 year.

The ReFLECT study was a prospective, observational cohort study conducted across multiple centers in France to evaluate real-world effectiveness and safety of intravenous CT-P13. The adult population with IBD included 530 patients with CD (71%), including 327 with no prior infliximab exposure, and 221 patients with UC (29%), including 152 who were infliximab-naive. The primary outcome of the study was persistence on CT-P13 after a 2-year follow-up period. Secondary outcomes included biochemical parameters, disease activity, and safety.

In patients with CD, the estimated persistence rate was 81.5% (95% CI, 76.7-86.6) at 1 year and 71.7% (95% CI, 66.7-77.0) at 2 years. Treatment persistence was higher in switched patients (83.7%; 95 % CI, 78.0-89.9) compared to infliximab-naive patients (65.7%; 95% CI, 58.6-73.7) with CD. In UC, the estimated CT-P13 persistence rate was 73.4 % (95% CI, 64.8-83.0) after 1 year and 63.7 % (95% CI, 55.3-73.3) after 2 years. Treatment persistence was also higher in switched patients with UC (91.2%; 95% CI, 81.7-100.0) compared to infliximab-naive patients with UC (53.4%; 95% CI, 43.0-66.2). The most common reasons for discontinuing CT-P13 treatment were treatment failure and intolerance in CD, and treatment failure, intolerance, and remission in UC.

Disease activity, indicated by Harvey Bradshaw Index, in CD, decreased over the follow-up period for infliximab-naive patients and remained stable for switched patients. In UC, Mayo score decreased over time in infliximab-naive patients, and decreased following the first CT-P13 administration, then remained stable in switched patients. In both CD and UC, C-reactive protein decreased over the follow-up period in infliximab-naive patients and remained stable in switched patients.

About half of patients (49.5%) reported at least 1 adverse event (AE). Serious AEs occurred in 13% of patients, and AEs with a possible relationship to CT-P13 treatment occurred in 18% of patients. Adverse events were “consistent with those from other prospective observational studies of CT-P13 in patients with IBD,” the authors wrote.

The authors said that their findings, consistent with previous observational studies, demonstrated maintained effectiveness of CT-P13 in more than 80% of switched patients over 2 years and “improved disease activity with sustained clinical benefit” in infliximab-naive patients.

Laharie D, Bouhnik Y, Vuitton L, et al. Real-world effectiveness and safety of CT-P13, an infliximab biosimilar, for inflammatory bowel diseases: A prospective national observational cohort study (ReFLECT study). Clin Res Hepatol Gastroenterol. 2024;48(10):102483. doi:10.1016/j.clinre.2024.102483

People with inflammatory bowel disease (IBD) who switched to the infliximab biosimilar CT-P13 had higher treatment persistence (84% and 91%) than those new to infliximab (66% and 53%), with no new safety concerns.

Clinical

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Patients With IBD Maintain Therapy 2 Years Post Switching to Infliximab Biosimilar

Paul Hahn on AMD biosimilars

Retina specialists have been cautious about adopting ranibizumab biosimilars, not due to efficacy concerns but because of cost-driven mandates like step therapy, raising fears that biosimilars will be forced upon them rather than remaining a choice. However, with growing experience, the field is adjusting.

According to Paul Hahn, MD, PhD, FASRS, a retina specialist and vitreoretinal surgeon at NJ Retina and a board member of the American Society of Retina Specialists, the upcoming aflibercept biosimilars may face a smoother integration, especially as insurance and cost considerations push patients away from branded Eylea.

Although real-world data confirm biosimilars' safety and effectiveness, the main concern is whether specialists will retain autonomy in treating age-related macular degeneration (AMD) and other retinal diseases. As more anti–vascular endothelial growth factor (VEGF) biosimilars enter the market, ongoing clinical experience will be key to building physician confidence.

This transcript has been edited for clarity; captions were auto-generated.

Based on your experience, how do retinal specialists perceive the ranibizumab biosimilars currently available on the market, and how appropriate do they consider them for treating patients with wet AMD?

People, and doctors in particular, are often very resistant or wary of change. When there's a new option on the market, if it doesn't fit their profile of what they're looking for, such as a new mechanism of action or a specific advantage, doctors may be a little bit wary of what that means, such as the case with biosimilars.

I think when biosimilars first became part of a consideration in the retinal armamentarium, there was a lot of hesitation around these. I think that exists because biosimilars are now here, not because of efficacy; they don't work better than our reference products. But it's a cost consideration, and many of us as doctors are used to not thinking about what costs less for the patient, but rather we're used to thinking about what works best for our patient. It's a different mindset.

Along the same lines, I think there's concern from a physician standpoint about how these biosimilars will be forced upon us as physicians. Right now, we like to treat our patients according to what medicine we think is best for them, but more and more, there are insurance mandates that require us to use what is often the cheaper medicine first. What we call step therapy, or what some people have referred to as a fail-first approach, allowing us to only use other therapies if they fail the less expensive drugs first.

With that history of step therapy mandates, I think there's a lot of hesitation to incorporating biosimilars because of this concern that it's going to be something that's forced upon us.

What are your thoughts on the upcoming entry of multiple aflibercept biosimilars into the US market, and how do you think they will impact access to care for patients with AMD ?

The entry of ranibizumab biosimilars has accustomed many retina specialists to the fact that biosimilars are now here, and aflibercept biosimilars may have an easier time at being incorporated. Certainly, many patients are on the aflibercept reference product, Eylea, and as patients need to be transitioned away from Eylea, either because of cost considerations, insurance mandates, or for whatever other reason, I think those aflibercept biosimilars are going to be one of the options. Again, I think for biosimilars in general, there's always going to be a cost consideration and a concern for retina specialists that cost is going to trump efficacy in treating patient disease, but I think what we'll all agree is that it's great that we have options for our patients. If biosimilars provide additional options for our patients, I think that's fantastic. 

Right now, in the beginning of 2025, we are seeing a lot of different events come into play, which is limiting access from retina specialists to therapies that they need. Along those same lines, having different options available, including biosimilars, is very important. As with ranibizumab biosimilars, I think the importance is how these biosimilars, including the aflibercept biosimilars, are pushed onto the retina specialists, whether it's something that the retina specialists maintain choice in administering or whether it's something that they are mandated to start first before trying a drug that the retina specialist may think is better for that patient in front of them.

What kind of evidence do you think is needed to make retinal specialists feel comfortable enough to regularly prescribe anti-VEGF biosimilars to their patients with AMD and other retinal diseases?

The burden of approval for biosimilars is different than the reference product. The clinical trial pathway is slightly different. Utilization of these biosimilars and real-world experience identifying that these biosimilars are effective and safe is going to be important, and we've seen that.

With the biosimilars on the market, we have seen that they are effective and that they are safe. In a recent database study that I've recently performed, we saw that in 2023, biosimilars in this database accounted for about 3% of utilization. And in 2024, it increased to about 10% of utilization.

Whether retina specialists are becoming more comfortable using them or whether they're being forced to use them more often is unclear from that study. But certainly, there's increased utilization of biosimilars. With that, as we hopefully learn that they are indeed safe and effective, I think retina specialists will feel more comfortable.

The introduction of biosimilars in the treatment of age-related macular degeneration (AMD) is raising concerns among physicians about cost-driven mandates and the autonomy to choose the best therapies for their patients, according to Paul Hahn, MD, PhD, FASRS, a retina specialist at NJ Retina.

Retina Specialists’ Evolving View on Biosimilars in AMD Treatment

Innovative statistical methods, such as simultaneous CIs and multiplicity-adjusted TOST (MATOST) were explored by researchers to address challenges posed by differing FDA and European Medicines Agency (EMA) regulatory requirements for biosimilar approvals, according to a review published in 

These differences have prompted research into innovative statistical methods for more efficient and accurate biosimilar assessments. When a biosimilar has both US and EU reference products, sponsors must conduct 3 bridging studies comparing the biosimilar product with the US-licensed reference product, the biosimilar product to the EU-approved reference product, and the US-licensed reference product to the EU-approved one.

Despite Europe's greater biosimilar adoption, regulatory disparities and complex US approval processes hinder development, underscoring the need for global harmonization.

The FDA and EMA also differ on foreign-approved comparators; the EMA permits them (with caveats), while the FDA requires 3-way comparisons.

Researchers criticize the conventional 3-way comparison for neglecting variability, underutilizing data, and creating multiple testing issues. This study investigated 2 alternatives, simultaneous confidence intervals and MATOST.

Regulatory Framework for Biosimilar Approval

Both agencies have slightly different definitions for biosimilars. The FDA defines biosimilars as biological products highly similar to the reference product, with no clinically meaningful differences between safety, purity, and potency compared with the reference product. However, the EMA defines biosimilars as biological medicinal products containing the same active substance as the reference product and similar in quality characteristics, biological activity, safety, and efficacy.

The FDA's stepwise approach assesses analytical similarity, investigating the structural and functional characteristics of the biosimilar product based on critical quality attributes at various stages of the manufacturing process. The stepwise approach includes a pharmacokinetics (PK) and pharmacodynamics (PD) similarity assessment, demonstrating PK and PD through human clinical pharmacology studies after passing animal toxicity studies, and a clinical similarity assessment, gathering information on immunogenicity, clinical efficacy, and safety.

Additionally, the main purpose of the 3-way comparison is to ensure the drug substance or product meets product specifications, to demonstrate biosimilarity between the test product and the US-licensed product, and to establish a bridge justifying the use of clinical data generated using the EU-approved reference product as the comparator. Strict requirements on biosimilar products are necessary to ensure the efficacy and safety of biosimilars on the market.

The drug sponsor should provide 3-way bridging evidence when using a non–US-licensed product in a regulatory submission for a biosimilar product. This evidence justifies the use of comparative data from the non–US-licensed product in assessing biosimilarity and bridging to the US-licensed reference product.

Disadvantages, such as underutilizing data collected from the entire study, can impair conventional pairwise comparisons, potentially biasing and misleading results. Since pairwise comparisons do not use the same reference product in each comparison, and each comparison may use a different equivalence acceptance criterion margin, the precision of each equivalence test varies. Multiple comparisons will inflate the type 1 error rate unless some significance-level adjustment approaches are considered. Overall, these pairwise comparisons cannot distinguish the relationship among the biosimilar product, the US-licensed reference, and the EU-approved reference.

Without loss of generality, the US-licensed reference product and the EU-approved reference product are considered as the 2 reference products, with the US-licensed reference as the primary reference.

Comparative Analysis of Statistical Approaches

The simultaneous CI method in a parallel study design used fiducial probabilities to perform pairwise equivalence tests. The simulation study used 4 methods for pairwise comparison and included 3 simultaneous CI methods with different assumptions and 1 conventional approach. The results found all approaches can maintain desired power when the sample size per arm is larger than 20. The simultaneous CI method under equal variability has the best performance among all the methods and can achieve similar statistical power to the conventional approach. The study found that the simultaneous CI method works well in parallel study design.

Among simulation results, the Holm and Bonferroni method were very conservative, and TOST was more likely to fail to reject the null hypothesis to control type 1 error inflation. In a crossover design with multiple formulations, especially within the Williams design, the MATOST method is not favorable since it may lead to an unrealistically large sample size, though it can control the type 1 error rate.

Addressing Challenges in Equivalence Testing

The FDA requires sponsors submitting biosimilar products for regulatory approval to conduct a 3-way pairwise comparison when both US-licensed and EU-approved reference products exist. Determining equivalence margins in the equivalence tests is crucial. Using sample estimation in the hypothesis setting is unnecessary because it does not consider the variability of the estimation.

Generalizing the CI method will allow researchers to determine equivalence margins by sampling standard deviations and considering the variability of the estimation. Researchers need to propose another method for controlling type 1 error inflation specifically for crossover designs to reduce the large sample size required for conducting a biosimilar study.

“For future research, it is possible to consider further utilization of fiducial inference under crossover designs and generalize the simultaneous CI method...,” the authors concluded. “Generalizing the simultaneous CI method can help researchers in determining equivalence margins by sampling standard deviations and taking the variability of estimation into consideration.”

Pong A, Chow S, Chow SC. Comparison of innovative and conventional methods in biosimilar bridging studies with multiple references. 

. 2024;18:377-387. doi:10.2147/btt.s470182

Jeremias S. Improving biosimilar access through global regulatory convergence. The Center for Biosimilars

. January 15, 2025. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/improving-biosimilar-access-through-global-regulatory-convergence

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements

After Wezlana (ustekinumab-auub) became the first ustekinumab biosimilar to enter the market in January 2025,

 3 others joined the fray, expanding access to lower-cost versions of blockbuster Stelara (ustekinumab).

Samsung Bioepis/Sandoz, Biocon Biologics, and Teva/Alvotech launched their respective ustekinumab products: Pyzchiva (ustekinumab-ttwe), Yesintek (ustekinumab-kfce), and Selarsdi (ustekinumab-aekn).

Amgen's launch of Wezlana was part of an exclusive agreement with Nuvalia, Optum Rx’s biosimilar procurement business comparable to CVS Health's Cordavis and Cigna/Express Scripts' Quallent.

 Although Wezlana was the first ustekinumab biosimilar to receive FDA approval and first to launch, the Nuvaila deal partially limits access to patients, creating an opportunity for other FDA-approved biosimilars to fill the gap.

Overall, there are 7 ustekinumab. biosimilars approved by the FDA, all of which are slated to launch throughout 2025. In addition to the 4 on the market, there are Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), and Steqeyma (ustekinumab-stba).

 All 7 are approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

Ustekinumab biosimilars were originally expected in 2023; however, patent lawsuits brought about by Janssen and its parent company Johnson & Johnson (J&J) resulted in every biosimilar company looking to bring a Stelara biosimilar competitor to market being forced to delay their launches until the first half of 2025, with Amgen winning the first launch spot.

Additionally, these products are looking to compete in a market where the reference drug generated $10.4 billion in sales in 2024, according to J&J’s most recent financial statement.

Over 58.5 million American adults have been diagnosed with a rheumatic disease, with some estimates predicting psoriatic arthritis affects between 6% and 41% of patients with psoriasis.

 Additionally, inflammatory bowel disease, which includes Crohn disease and ulcerative colitis, is estimated to impact between 2.4 million and 3.1 million Americans, according to the CDC.

“The burden of Crohn’s disease and ulcerative colitis on patients’ daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available,” Laura Wingate, chief education, support, and advocacy officer of the Crohn’s and Colitis Foundation, commented.

Biocon Biologics said that Yesintek will have commercial payer coverage at launch, as well as a patient assistance product that includes verification and co-pay support, among other services. The program is similar to the one offered for the reference product, and eligible patients could pay as little as $0 for the biosimilar.

Pyzchiva and Selarsdi were developed as part of exclusive commercialization agreements between a smaller international company and a larger American corporation. In the case of Pyzchiva, Samsung Bioepis oversaw development, registration, intellectual property, manufacturing, and supply, while Sandoz manages commercialization.

 Similarly, Selarsdi was developed by Alvotech and is commercialized by Teva.

Of the 3 newly launched products, only Pyzchiva provisionally determined Pyzchiva to be interchangeable, but it can’t officially have the dedication until Wezlana’s 1-year exclusivity for being the first interchangeable ustekinumab biosimilar has lapsed.

 Once it has the full designation, pharmacists will be able  substitute the reference drug with the Pyzchiva without waiting for provider approval, allowing patients to have easier access to their medications, particularly in the event of a drug shortage or supply chain issue.

1. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars

. January 31, 2025. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us

2. Samsung Bioepis announces US launch of Pyzchiva (ustekinumab-ttwe), biosimilar to Stelara. Press release. Samsung Bioepis. February 24, 2025. Accessed February 24, 2025. 

https://www.businesswire.com/news/home/20250223623917/en/Samsung-Bioepis-Announces-US-Launch-of-PYZCHIVA%C2%AE-ustekinumab-ttwe-Biosimilar-to-Stelara

3. Biocon Biologics launches Yesintek (ustekinumab-kfce) biosimilar to Stelara in the United States. Press release. Biocon Biologics. February 24, 2025. Accessed February 24, 2025. 

https://www.bioconbiologics.com/biocon-biologics-launches-yesintek-ustekinumab-kfce-biosimilar-to-stelara-in-the-united-states/

4. Teva and Alvotech announce Selarsdi (ustekinumab-aekn) injection now available in the U.S. Press release. Teva Pharmaceuticals. February 21, 2025. Accessed February 24, 2025. 

https://www.tevapharm.com/news-and-media/latest-news/teva-and-alvotech-announce-selarsdi-ustekinumab-aekn-injection-now-available-in-the-u.s

5. Biosimilar approvals. The Center for Biosimilars. Updated February 24, 2025. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/biosimilar-approvals

6. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. The Center for Biosimilars. May 29, 2023. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

7. Johnson & Johnson reports Q4 and full-year 2024 results. J&J. January 22, 2025. Accessed February 24, 2025. 

https://www.investor.jnj.com/news/news-details/2025/Johnson--Johnson-Reports-Q4-and-Full-Year-2024-Results/default.aspx#:~:text=2024%20Fourth%2DQuarter%20reported%20sales,quarter%20and%20full%20year%202024

8. American College of Rheumatology Releases 2022 Rheumatic Disease Report Card. Press release. American College of Rheumatology. September 15, 2022. Accessed February 24, 2025. 

https://rheumatology.org/press-releases/american-college-of-rheumatology-releases-2022-rheumatic-disease-report-card

9. Ogdie A, Weiss P. The epidemiology psoriatic arthritis. 

. 2015;41(4):545-568. doi:10.1016/j.rdc.2015.07.001

10. IBD facts and stats. CDC. Accessed February 24, 2025. 

https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html

11. Jeremias S. FDA approves Samsung Bioepis’ Pyzchiva, a biosimilar to Stelara. The Center for Biosimilars. July 1, 2024. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-samsung-bioepis-pyzchiva-a-biosimilar-to-stelara

Three ustekinumab biosimilars enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the most profitable drugs in the world.

3 Ustekinumab Biosimilars Launch on US Market

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?

Enhancing Biosimilar Adoption in Value-Based Oncology Care

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, highlighted biosimilars' role in making cancer care more affordable and accessible, especially for underserved populations. He stressed the need to balance cost-effectiveness with efficacy and called for greater payer trust in oncologists' biosimilar selections. Brewer also advocated for expanding "gold carding" to reduce prior authorization hurdles, promoting smoother biosimilar adoption in value-based care models.

In a value-based oncology care model, what role do biosimilars play in ensuring equitable access to cancer treatments, especially for underserved patient populations?

Well, to the extent that you have, , biosimilars available, that that may be more cost effective, yet equally efficacious, relative to a particular treatment regimen, I think that goes a long way. Going back to the original cost-containment idea, so the more affordable you can make cancer care, the more accessible it is to to to broader populations.

That said, it's not always the best idea to just pick the cheapest if the cheapest isn't the best. You have to balance that with the efficacy of the treatment.

Can value-based oncology care models incentivize more rapid biosimilar uptake, and if so, what mechanisms should be in place to ensure their successful implementation?

That's really where the payers come in. We, as a practice, do a very good job of monitoring what's available on the market, what is the most efficacious, and then balance that with what is the most cost-effective. Unfortunately, at times we'll find that what we think the correct answer is, is not what the payer prefers, and the payer prefers brand B, C, or D.

And then it becomes a little difficult from a practice management perspective to keep on hand every "flavor" of biosimilar that's out there. I've told payers before we are not Baskin-Robbins. We don't carry all the flavors. That can lend itself to some conflicts with the payer.

So, I think the payers opening themselves up to trusting the community oncology providers a little more relative to the selection of biosimilars would go a long way in this space.

How do current reimbursement policies and payer models impact the integration of biosimilars into value-based oncology care, and what changes are necessary to promote their wider adoption?

I think opening up some of the prior authorization guidelines, more gold carding for trusted physician groups. I push for a gold card every chance I get, and I have absolutely no issue with with a payer coming back on the back end and saying, "Okay, well, let me take a look at 10- year files and see if it's not the fox guarding the hen house here."

We really are doing the right things for the right reasons. So, I think there's an opportunity to partner more with the payers on that front and get the payers to back off. And the best way to get them to back off is to show that we are consistently providing the highest-value care in the most cost-effective manner.

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, discusses the role of biosimilars in making cancer care more affordable and accessible, as well as the need for greater payer trust in oncologists’ treatment decisions.

The Center for Biosimilars Staff

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