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WHEN CHOICE ARRIVES: Competition & Consequences

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Cameron Santoro is an associate editor for The Center for Biosimilars

Articles

Patients with rheumatoid and psoriatic arthritis maintained stable disease activity and functional capacity, with even some improvement in ultrasound findings, after switching from original adalimumab to its biosimilar, GP2017.

Adalimumab Biosimilar Maintains Effectiveness for Patients With Arthritis and Health Care Costs

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

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

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases, and ophthalmic conditions.

New Approvals Expand Access to Biosimilars for Ophthalmology, Bone, and Joint Conditions

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

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

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Robert Popovian is a leader in health care and biopharmaceuticals who is accomplished in pharmaceutical science, business and government, with a distinctive array of academic and practical experience across a wide range of healthcare and business management functions. Positioned at the intersection of economics, policy, and innovation which maximizes patient access.

If every adalimumab biosimilar had an interchangeability designation, the United States could save additional $765 million annually, according to calculations from 3 biosimilar experts.

Contributor: What Is the Value of the Interchangeability Designation for a Biosimilar?

Biosimilars provide significant savings and encourages competition in the biopharmaceutical marketplace but the United States needs to do more to empower uptake and address adoption barriers, according to Robert Popovian PharmD, MS.

Opinion: Biosimilar Adoption Will Help Achieve a Bipartisan Goal

Government price negotiations for certain products under the Inflation Reduction Act (IRA) that aimed to rein in high drug costs may have had unintended consequences for biosimilar development, according to a new report from Matrix Global Advisors (MGA).

The report comes after a separate IQVIA Institute for Human Data Science report claimed that the globe could face what the report called a “biosimilar void.”

 Essentially, 90% of the biologics scheduled to lose exclusivity in the next decade, valued at $234 billion, do not currently have biosimilars in development, showcasing a large, missed opportunity for developers.

Although the negotiated prices don’t go into effect until 2026, the first 10 products chosen for the program have been announced.

 Only products that were not at risk of having biosimilars enter the market in the next few years were supposed to be eligible for Medicare price negotiation. However, the initial list includes Stelara (ustekinumab) and Enbrel (etanercept). Several biosimilars for Stelara are currently on the market, and 2 biosimilars for Enbrel (etanercept) have been approved by the FDA, with potential launches scheduled for 2029.

“Almost all the Medicare negotiated drugs have a generic or biosimilar equivalent in the pipeline, which in turn have a significantly lower cost,” said John Murphy III, president and CEO of the Association for Accessible Medicines, in a statement on the report.

 “The Medicare drug price negotiation program artificially extends the lifecycle of the brand version, resulting in higher costs for seniors.

The MGA analysis quantified the real-world implications not only on the cost of medicines but also on the long-term negative impact on future development of generics and biosimilars, which will result in fewer competitors and more delayed competition. The better option is the proven success of reducing drug prices through generic and biosimilar competition.”

The analysis revealed that the threat of price negotiations might deter manufacturers from launching biosimilars, especially for high-sales biologics.

 A 2024 Samsung Bioepis report indicated that after entering the market, biosimilars typically achieved a 53% market share with an average 53% decline in sales price relative to the reference biologic over 5 years.

 However, given the risks and costs involved, the MGA report estimated that for each biologic with $3.5 billion in annual sales, potentially $1.9 billion in annual savings could be lost if biosimilar entry was delayed due to government negotiations.

“In the current environment, the threat of government intervention appears to be chilling the incentives for biosimilar manufacturers to enter and compete effectively in the market,” noted the report. Unlike generics, biosimilars require steep investment, and future revenues often remain uncertain. That long timeline and financial risk, combined with government pricing uncertainty, appeared to be making some manufacturers think twice before investing.

Long-term Implications for Access and Cost

The report highlighted that these delays could impact patient access to affordable biologic therapies. Biosimilars serve as a crucial mechanism to lower treatment costs for complex conditions such as rheumatoid arthritis and certain cancers. Yet, the hesitancy among manufacturers resulting from the policy environment could blunt this potential.

According to Samsung Bioepis’ report, biosimilars continued to reduce prices by 24% to 76%, depending on therapeutic areas, but the “chilling effect” posed a threat to widespread continued price declines and broader market penetration in the future.

 “The reluctance of firms to develop biosimilars due to the risk of government price negotiations will hinder the full realization of biosimilar cost savings,” the present report stressed.

Recommendations to Address the Biosimilar Gap

To mitigate the detrimental effects of the so-called “biosimilar void,” the report offered several policy recommendations. Foremost among these was re-evaluating the use of price negotiations as a tool for controlling drug costs, emphasizing the importance of fostering competitive markets instead of suppressing biosimilar market entry.

Experts suggested that policy efforts should focus on reducing anticompetitive behaviors, including patent thickets that delay biosimilar approvals. The authors highlighted that patent thickets can impede biosimilar entry, and addressing these barriers could unlock significant savings and increase biosimilar availability.

Additionally, the report called for improved market transparency and targeted incentives for biosimilar manufacturers. “Creating a more predictable and supportive environment for biosimilar development could significantly narrow the current void," the authors wrote.

While policies aimed at reducing drug costs are vital, the report cautioned that aggressive government price negotiations might inadvertently stifle biosimilar development, ultimately undermining efforts to make biologic therapies more affordable. Moving forward, policymakers were encouraged to balance cost containment measures with strategies designed to promote biosimilar competition, ensuring equitable access to these complex therapies for patients and health systems alike.

1. Brill A, Robinson C. Long-term effects of Medicare price negotiations on drug competition. Matrix Global Advisors. July 14, 2025. Accessed July 15, 2025. 

https://accessiblemeds.org/wp-content/uploads/2025/07/Matrix_Global_Advisors_Long-Term_Effects_of_Medicare_Drug_Price_Negotiations.pdf

2. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars

. February 5, 2025. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars

3. Jeremias S. Stelara and Enbrel chosen for IRA price negotiation. The Center for Biosimilars. August 29, 2023. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/stelara-and-enbrel-chosen-for-ira-price-negotiation

4. Jeremias S. More ustekinumab biosimilars join US market share fight. The Center for Biosimilars. March 13, 2023. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/more-ustekinumab-biosimilars-join-us-market-share-fight

5. Biosimilar approvals. The Center for Biosimilars. Updated July 1, 2025. Accessed July 15, 2025. 

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

6. Medicare drug price negotiation has chilling effect on generic and biosimilar medicines development and availability. News release. Association for Accessible Medicines. July 15, 2025. Accessed July 15, 2025. 

https://accessiblemeds.org/resources/press-releases/medicare-drug-price-negotiation-has-chilling-effect-on-generic-and-biosimilar-medicines-development-and-availability

7. Santoro C. Samsung Bioepis reports 2024 biosimilar market growth trends. 

. October 15, 2024. Accessed July 15, 2025. 

https://www.ajmc.com/view/samsung-bioepis-reports-2024-biosimilar-market-growth-trends

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.

Business & Practice

Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap

 assessed the safety of the infliximab biosimilar CT-P13 (Inflectra) after switching from the reference product (Remicade) in Japanese patients with Crohn disease (CD), ulcerative colitis (UC), and rheumatoid arthritis (RA). Among patients with CD, 39% experienced at least one uncommon adverse drug reaction (ADR), as well as 50% of patients with UC and 13% with RA. However, most ADRs (94%) were considered not related to CT-P13.

The tumor necrosis factor (TNF)-α inhibitor infliximab is used to treat a variety of immune-mediated inflammatory diseases, including IBD (CD and UC) and RA, in which the cytokine TNF plays a central role. 

 was the first infliximab biosimilar and first biosimilar monoclonal antibody approved in Japan in 2014. Clinical trials and real-world studies have established CT-P13 is similarly effective and safe as the originator, however, according to the authors, there are few studies on long-term CT-P13 treatment in Japan, where patient co-pays for biosimilars and originators are the same.

Data on 220 patients was collected in routine clinical practice at multiple centers in Japan, 123 of whom had CD, 74 with UC, and 23 with RA. Patients were stable on the reference product prior to switching to CT-P13. The study is ongoing with patients continuing to complete annual follow-up visits.

After 2 years of CT-P13 therapy, 48 (39%), 37 (50%), and 3 (13%) patients with CD, UC, and RA reported at least 1 ADR. However, the vast majority (94%) were not related to CT-P13. Most ADRs (74%) were grade 1 or 2. The most frequent classes of ADRs reported were gastrointestinal disorders in 11% of patients with CD, infections and infestations in 20% of patients with UC, and injury, poisoning, and procedural implications in 9% of patients with RA.

Adverse events (AEs) and serious AEs (SAEs) were secondary endpoints of the study. AEs were reported by 59% of patients with CD, 70% of patients with UC, and 30% of patients with RA. Serious AEs were reported by 10%, 13.5%, and 9% of patients. Most AEs were grade 1 or 2 and most SAEs were grade 2 or 3. The most frequent AEs were gastrointestinal disorders in patients with CD (40%) and UC (40.5%), and infections and infestations in patients with RA (17%). Herpes zoster infection and pneumonia in patients with CD and UC and nasopharyngitis in patients with RA were considered to have a “plausible relationship to CT-P13 treatment.” One patient with CD and 4 patients with UC reported infusion-related reactions.

Nineteen patients (9%) discontinued CT-P13 for reasons related to the drug, 4 (9%) with CD, 11 (31%) with UC, and 4 (31%) with RA. The primary reason was loss of efficacy in patients with UC and RA, and AEs in patients with CD. Two patients with CD and 1 with UC experienced SAEs leading to discontinuation of treatment.

The authors concluded that CT-P13 was “well tolerated” over 2 years in this study, as most ADRs were not related to CT-P13, and few patients stopped treatment due to reasons related to the biosimilar. They added that the effectiveness of infliximab therapy was “well maintained,” and said their findings demonstrate long-term safety of CT-P13 in real-world practice. They plan to report 5-year data at the completion of the study.

Ishida T, Yokoe I, Obata H, Park S, Kim S, Nishimata N. A real-world, observational, prospective cohort study evaluating the safety and effectiveness of CT-P13 in inflammatory bowel disease and rheumatoid arthritis: the MEGA-J study. 

. 2025;41(4):601-606. doi:10.1080/03007995.2025.2492638

The MEGA-J study reveals CT-P13's long-term safety and effectiveness in treating inflammatory bowel disease and rheumatoid arthritis, with minimal adverse reactions.

Clinical

Real-World Data Suggest Long-Term Safety of CT-P13 in IBD, RA

 on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

The requirements for FDA approval of biosimilars are appropriate.

There is no longer any need for comparative clinical efficacy trials.

The requirements for demonstration of biosimilarity need to be increased.

Check out the results from our last poll:

There are diverging opinions on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

Polls

Biosimilars Poll: What is Your Opinion on Clinical Efficacy Trials?

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health.

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, and Chris O'Dell, senior vice president of market solutions at Turquoise Health, discussed key misconceptions about pharmacy benefit manager (PBM) impact on biosimilar adoption and evolving industry dynamics in an interview with The Center for Biosimilars

Canavan outlined major trends impacting PBMs, including a significant move towards transparency, driven by new legislation and demands from health plans and members for clear savings and passed-on benefits. He also emphasized a growing focus on value-based care, shifting PBMs from a sole focus on the bottom line to prioritizing patient outcomes, quality of care, and preventative measures.


O'Dell highlighted a major misconception regarding cheaper biosimilars that are believed to automatically translate to lower reimbursement and overall costs. He explained that hospitals and pharmacies often receive similar reimbursement for biosimilars as for brand-name drugs, leading to "spread pricing" where PBMs acquire drugs for less but charge employers/insurers similarly, thus not passing on the full savings.


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

The intricate world of pharmacy benefit managers, or PBMs, play a pivotal role in the health care ecosystem, influencing everything from drug pricing to patient access. Despite their widespread impact, a clear understanding of their functions and effects remains elusive for many.

What are the most significant misconceptions or information gaps regarding PBM impact on biosimilar adoption, and how do you foresee these dynamics evolving alongside the major trends impacting PBMs in the coming year?

I think the first one that will be the biggest trend is around transparency. We've already seen a lot of transparency, PBMs start to develop, and with the PBM Transparency Act, which passes on certain medication savings, it prohibits unfair practices, and can now be enforced by the FTC [Federal Trade Commission], PBMs are definitely trending more towards transparent practices. The health plans want to see what the actual savings are from the PBM, and then members want to know that the PBM is working for them. They also want to see those savings get passed on as well.


The second trend is around value-based care. Right now, there's a focus on quality of care, and there's a growing focus on the total outcomes for the patient, more than simply the bottom line. It also focuses on provider performance, best practices, evidence-based medicine, and there's also a focus on patient experience. With value-based care, you have care coordinators that work with patients, there's a focus on preventative medicine, and then it also tries to remove barriers around transportation. Then, it looks a lot at patient goals, and so PBMs are really starting to look at value-based care more, instead of just the bottom line.


Then, the next trend I think we'll see is around reducing prescription cost. Right now, there's a big focus on specialty GLP-1s [glucagon-like peptide-1], those are expensive medications. PBMs are trying to control them with prior authorizations and step therapy. I think we'll start to see more around lower-cost alternatives and decreasing poor outcomes, specifically around polypharmacy.


The biggest misconception around biosimilar adoption is that just because a drug is cheaper or produced for cheaper or costs less, that it means it's reimbursed less. There are many examples where the biosimilar might be acquired for significantly less, but whether it be payment from the insurance to the hospital or payment to the pharmacy, the reimbursement is not much less than what it would be for the brand-name drug.


This whole promise that these would drive down cost is a little bit of a misconception so far, because hospitals are often getting paid the same amount. On the PBM side, this is called spread pricing, which is when, effectively, the amount that they're paying to the pharmacy is a lot less than what they're acquiring it for. In essence, it costs the same to the employer or the insurer. I think that's probably the biggest misconception, that these will be cheaper, they'll drive down costs, and we just haven't seen that yet.

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

In response to the need for more real-world evidence on adalimumab biosimilars, new findings from a large cross-sectional survey across France, Germany, Italy, Spain, and the UK offer compelling insights into the practical benefits of ABP 501 (Amgevita/Amjevita), a leading adalimumab biosimilar.

The treatment of debilitating immune-mediated inflammatory diseases (IMIDs) like rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and psoriasis (PsO) has seen a dramatic shift with the introduction of adalimumab biosimilars.

, involving 1296 patients who either started on ABP 501 or switched from the reference product (Humira), directly tackled critical questions about its real-world effectiveness, patient satisfaction, and impact on daily life.

The data emphatically demonstrated that ABP 501 delivered positive treatment outcomes, earning high satisfaction marks from both patients and their treating physicians, regardless of prior exposure to the reference product. Physicians reported overwhelming satisfaction with disease control provided by ABP 501. Among patients who initiated ABP 501 as their first advanced therapy, physician satisfaction rates exceeded 89% across all disease cohorts, even reaching more than 95% in AS, PsA, and PsO.

For those initiating ABP 501, a significant majority of patients across all IMIDs were assessed by their physicians as having mild disease at the time of consultation—ranging from 63.2% in AS to an impressive 83.0% in PsO after a median of 10.4 to 12.3 months on the biosimilar. Pain levels also showed remarkable improvement, with a large proportion of patients experiencing mild or no pain.

Patients echoed their physicians' positive assessments. A substantial majority of ABP 501 initiators, more than 86% across all indications, reported high satisfaction with their treatment regimen. Importantly, their health-related quality of life (HRQOL) measures consistently indicated minimal disease impact on their daily lives. Low scores for work productivity and activity impairment further emphasized the biosimilar's positive effect on patients' ability to participate in daily activities and work.

The study also shed light on the experiences of patients who transitioned from the reference product to ABP 501. The drivers for these switches were often pragmatic, with physicians citing formulary-driven switches, financial considerations, and insurance restrictions as primary reasons. Crucially, these non-clinical motivations did not translate into compromised patient care or satisfaction. Both physicians and patients maintained high satisfaction levels with ABP 501 after the switch, exceeding 93% for physicians and at least 94.7% for patients across indications. Moreover, patient-reported HRQOL remained strong following the switch, demonstrating a seamless transition without any discernible negative impact on patient well-being or treatment efficacy. This finding is particularly significant for managed care organizations, as it helps to alleviate concerns about potential "nocebo effects" sometimes associated with biosimilar transitions.

This robust real-world evidence provides compelling arguments for managed care organizations to fully embrace adalimumab biosimilars like ABP 501. Driven by financial and administrative advantages, these biosimilars offer a significant opportunity to reduce health care expenditures for IMID management, leading to more efficient resource allocation and benefiting a broader patient population.

The high satisfaction among both physicians and patients, coupled with positive clinical outcomes, should bolster confidence in prescribing biosimilars, especially for extrapolated indications. The sustained high HRQOL and satisfaction reported by patients after switching underscore that biosimilars maintain positive patient experiences and promote adherence.

Another real-world analysis focusing on nonmedical switching from the adalimumab originator to adalimumab biosimilars revealed that patient-reported outcomes were maintained post-switch, showing the continued safety and efficacy for patients with chronic inflammatory conditions.

The authors of the present study concluded, “Our findings add to the growing body of real-world experience with biosimilar use which help address barriers to utilization due to lack of awareness and concerns about inadequate efficacy from both patients and physicians, especially for indications approved on the principle of extrapolation and for patients who switch from the reference product.”

1. Jin R, Haughton JM, Goddard EJ, et al. Real-world experience with an adalimumab biosimilar (ABP 501) in patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis in Europe: results from the Adelphi Disease Specific Programme. 

. 2025;12(3):469-492. doi:10.1007/s40744-025-00755-9

2. Jeremias S. Study on nonmedical switching for adalimumab biosimilars warns about nocebo effect. The Center for Biosimilars

. April 27, 2023. Accessed June 2, 2025. 

https://www.centerforbiosimilars.com/view/study-on-nonmedical-switching-for-adalimumab-biosimilars-warns-about-nocebo-effect

New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases.

European Data Confirm Real-World Benefits of Adalimumab Biosimilars

(Otulfi; Fresenius Kabi) had no clinically relevant effect on efficacy, safety, or immunogenicity and demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate to severe plaque psoriasis, supporting its therapeutic equivalence and potential for broader application in other indications, according to a study published in 

Even though biological therapies showed improvements in psoriasis management and other inflammatory conditions, high costs continue to limit access. Over the past decade, adalimumab, infliximab, and etanercept biosimilars have been adopted which have helped increase the number of patients who benefit from treatment.

Previous researchers found that patients with psoriasis who received either adalimumab, etanercept, or ustekinumab underwent dose escalations more frequently with ustekinumab compared with the other 2 treatments.

 They also discontinued treatment after dose escalation occurred more often with adalimumab and etanercept than with ustekinumab.

Currently, US regulatory bodies require evidence that the molecule is like the reference product in terms of structure, function, pharmacokinetics, clinical efficacy, and safety for biosimilar approval.

 Researchers have proposed dropping these blanket requirements, deeming them redundant, and modeling regulatory agencies after the United Kingdom and European Union.

Researchers conducted a multicenter randomized, double blind, parallel group phase 3 study across 27 sites in Estonia, Georgia, Poland, and Ukraine.

 About 40% of the patient population was women with an average age of 42 years, with a 24.4 mean Psoriasis Area and Severity Index (PASI) score. Of the patients, 19.4% reported prior systemic biological treatment for psoriasis, and only 9.2% of these reported an inadequate response or intolerance.

Researchers randomized a total of 392 patients to either FYB202 (n = 197) or reference ustekinumab (n = 195). Some patients did not respond (FYB202, 4; reference ustekinumab, 5), and a few patients in the reference ustekinumab group did not undergo rerandomization due to adverse events (AEs) leading to study discontinuation (n = 2) or nonattendance at week 28 (n = 1).

In the FYB202 group, 189 patients continued treatment to week 52, and researchers rerandomized 186 in the reference group (FYB202, 89; reference ustekinumab, 97). Following rerandomization, 372 patients completed the study until week 52. There were 187 patients who remained on FYB202, 97 patients who remained on reference ustekinumab, and 88 patients who switched from reference ustekinumab to FYB202.

Patients treated with FYB202 showed an estimated mean percent improvement in PASI score of 79.5% (95% CI, 74.6%-84.4%) for the primary end point from baseline to week 12, while patients treated with reference ustekinumab achieved 76.2% (95% CI, 71.5%-81%). All secondary efficacy end points were also similar between treatment groups.

Percentages of patients who reached PASI 75 (FYB202, 97.9%; reference ustekinumab, 96.4%) and PASI 90 (FYB202, 81.7%; reference ustekinumab, 78.2%) at week 28 were similar. Switching from reference ustekinumab to FYB202 had no impact on therapeutic efficacy. A total of 97.7% patients in the switch group maintained their PASI 75 response at week 52.

No differences emerged between the groups that maintained their initial treatment for the entire 52 weeks. A PASI 75 response at week 52 was maintained by 96.2% of patients in the FYB202 group and 94.6% of patients in the reference ustekinumab group.

Both treatments patients tolerated well, and researchers found the safety profiles comparable between groups. Patients reported at least 1 AE during the first 28 weeks in 39.6% of the FYB202 group and 41% of the reference group. Before rerandomization, patients most frequently reported injection site pain (FYB202, 11.2%; reference ustekinumab 7.7%), nasopharyngitis (FYB202, 4.6%; reference ustekinumab, 2.6%), and COVID-19 (FYB202, 3.6%; reference ustekinumab, 2.6%).

AEs caused 1% of patients treated with FYB202 and 1.5% of patients treated with reference ustekinumab to withdraw from the study. After rerandomization, 3 patients in the FYB202 group, 1 patient in the reference ustekinumab group, and 1 patient in the reference ustekinumab to FYB202 switch group reported serious AEs. Only 1 patient in the reference ustekinumab to FYB202 switch group discontinued because of an AE (congenital anomaly).

At baseline, 5.1% of patients in the FYB202 group and none in the reference ustekinumab group had confirmed positive adenosine deaminase (ADA) tests. ADA prevalence from week 4 to week 52 was lower for FYB202 compared with reference ustekinumab. Researchers observed the maximum proportion of patients with ADAs at week 28 in both groups.

After rerandomization, ADA and neutralizing antibody positivity declined in all 3 groups. No patients who were ADA negative at week 28 became ADA positive following the switch from reference ustekinumab to FYB202, indicating that the switch from reference ustekinumab to FYB202 did not impact immunogenicity. Mean percent improvement in PASI score from baseline to week 12 was slightly lower in ADA positive patients compared with ADA negative patients, and both treatment groups showed a similar reduction.

Researchers observed higher geometric mean C

 levels for patients treated with FYB202 compared with patients treated with reference ustekinumab, especially at early time points, which may be due to the differences in ADA incidences at the early time points as well some differences in the protein content. The serum C

 levels of ustekinumab showed a high interpatient variability particularly at weeks 4 and 12. Researchers observed smaller interpatient variability during steady state at weeks 16, 28, 40, and 52. They also observed similar and stable C

 levels from week 16 to week 52 in all 3 rerandomized groups from week 28 to week 52.

The study was not powered for statistical comparisons of equivalence after switching from reference ustekinumab to FYB202. Researchers included only a single switch, but clinical practice may involve multiple treatment switches. Additionally, regulatory authorities required the trial to detect differences between treatments for biosimilar approval, not to prove 

 efficacy. Researchers selected a narrower patient population than clinical practice might expect to ensure comparison sensitivity. Finally, the study lacked racial diversity as all patients were White, but extrapolation allows inferring similar treatment effects for other populations.

“Using a totality of evidence approach, proof of therapeutic equivalence in this sensitive psoriasis population allows for extrapolation to other indications, with similar clinical performance of FYB202 and reference ustekinumab assumed across all approved indications,” study authors concluded.

1. Papp K, Balser S, Nopora K, et al. A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the biosimilar ustekinumab FYB202 with reference ustekinumab in patients with moderate-to-severe plaque psoriasis. 

. 2025;42:2135-2149. doi:10.1007/s12325-025-03138-2

2. Santoro C. Differences in psoriasis treatment: ustekinumab dose escalation vs adalimumab, etanercept discontinuation. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/differences-in-psoriasis-treatment-ustekinumab-dose-escalation-vs-adalimumab-etanercept-discontinuation

3. Niazi SK. BioRationality: a new bill to transform the future of biosimilars. The Center for Biosimilars. May 5, 2025. Accessed June 9, 2025. 

https://www.centerforbiosimilars.com/view/biorationality-a-new-bill-to-transform-the-future-of-biosimilars

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

Robert Popovian, PharmD, MS

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