Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

Here are the top 5 biosimilar articles for the week of June 30, 2025.

 use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults.

: About 13% of patients who switch from Humira to an adalimumab biosimilar switch back to the originator, according to research from Truveta. However, the presented data 

: A real-world study reveals that pediatric patients with IBD achieve 

: Regulators and manufacturers advance biosimilars for 

, enhancing access to treatment in Europe and Latin America.

 raises critical concerns about FDA standards, physician trust, and patient safety in biosimilars.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of June 30

Biosimilar SB12 demonstrated comparable efficacy and safety for paroxysmal nocturnal hemoglobinuria (PNH) to its reference drug, showing similar outcomes across diverse patient groups. | Image Credit: Innovative Creation - stock.adobe.com

Biosimilar SB12 or Epysqli (eculizumab-aagh; Samsung Bioepis) is equivalent to reference eculizumab (Soliris) for treating complement inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH), showing no significant differences in transfusion avoidance or hemoglobin stabilization across both Asian and non-Asian subgroups, according to a study published in 

PNH is a rare blood disorder that causes brown/dark-colored urine during late nights or early mornings, typically affecting men and women between 30 and 40 years old.

 PNH can lead to hemolytic anemia, chronic kidney disease, or thrombosis, and individuals with bone marrow disorders are at risk of developing PNH.

PNH arises from a somatic mutation in the phosphatidylinositol glycan class-A gene.

This genetic defect leads to a deficiency of crucial glycosylphosphatidylinositol-anchored proteins, specifically CD55 and CD59, on the surface of blood cells. The absence of these regulatory proteins results in uncontrolled activation of the complement system, which then attacks and destroys red blood cells, leading to intravascular hemolysis. Episodes of severe hemolysis, known as paroxysms, are often triggered by stressors such as surgery, infection, or inflammation.

The FDA approved SB12 in July 2024 for both PNH and atypical hemolytic uremic syndrome, based on results from phase 1 (

 This approval was the second eculizumab biosimilar approved, following Bkemv (eculizumab-aeeb) in May 2024.

Researchers conducted a randomized, double-blind phase 3 study between August 2019 and October 2021 at 24 centers across 8 countries to evaluate treatment sequences for PNH.

 There were 50 adult patients with PNH who were randomized to treatment sequence 1 (TS1, SB12-ECU; n = 25) or 2 (TS2, ECU-SB12; n = 25). Both treatments were administered intravenously, starting with 600 mg weekly for the first 4 weeks, increasing to 900 mg in the fifth week, and then 900 mg biweekly thereafter. At week 26, patients were switched to the alternative treatment, continuing until week 50.

The phase 3 study had Asian patients constituting 54% of the total enrollment. Of the 25 patients randomized to TS1 (SB12-ECU), 60% were Asian and 40% were non-Asian. For the 25 patients randomized to TS2 (ECU-SB12), the distribution was 48% Asian and 52% non-Asian.

The 95% CIs for the mean difference in lactate dehydrogenase (LDH) levels at week 26 between SB12 and eculizumab fell within the predefined equivalence margins for both Asian patients (SB12-ECU, –12.02; 95% CI, −126.87 to 102.83) and non-Asian patients (SB12-ECU, 76.12; 95% CI, −56.75 to 208.99), indicating that SB12 is equivalent to eculizumab in terms of LDH levels for both groups.

The 90% CI for the ratio of time-adjusted area under the effect curve of LDH between SB12 and eculizumab indicated equivalence in Asian patients (SB12/ECU, 1.01; 90% CI, 0.92-1.10), as it fell within the predefined equivalence margin. This comparable outcome was also observed in non-Asian patients, where the ratio was 1.15 with a 90% CI of 0.90 to 1.46.

LDH levels showed a significant drop in both Asian and non-Asian participants after the initial dose, remaining below 2 times the upper limit of normal from week 3 onward. Prior to screening, the mean packed red blood cell (pRBC) units transfused over 12 months were 6.4 units in planned TS1 (SB12-ECU) and 3.8 units in planned TS2 (ECU to SB12).

Throughout the study, the mean number of pRBC units transfused was similar between treatment sequences for Asians (planned TS1, 4.6 units; planned TS2, 4.5 units) and non-Asians (planned TS1, 0.5 units; planned TS2, 1.0 units).

Across the entire study population, 60% of patients received at least one unit of pRBCs in the year before screening, with slightly more in TS1 (64%) than TS2 (54%). Transfusion avoidance was observed in 68.1% of patients receiving SB12 and 72.9% of patients receiving eculizumab, with a difference of -5.3% (95% CI, –18.9% to 8.4%; 

In the Asian subgroup, there was a noticeable increase in transfusions in TS2 over time (from 41.7% to 60%) compared with TS1 (from 57.1% to 76.9%). Conversely, non-Asian subgroups showed similar rates of transfusion avoidance between TS1 (70% to 100%) and TS2 (76.9% to 84.6%).

When analyzing hemoglobin stabilization in Period 1 subjects (treated with SB12 or eculizumab before switching), 2 criteria were used due to a lack of standardization in measurement. Using the less stringent Criterion 1, the difference in hemoglobin stabilization between SB12 and eculizumab (SB12-ECU) was 6.3% (95% CI, –21.5% to 34.1%) across the entire study population. This difference was more pronounced in Asian subjects, at 25% (95% CI, –10.9% to 60.9%), and non-Asian subjects showed a difference of –6.9% (95% CI, –43.4% to 29.6%).

Under the more stringent Criterion 2, the overall difference in hemoglobin stabilization (SB12-ECU) was 2.5% (95% CI, –24.8% to 29.8%). For Asian subjects, this difference was 15.5% (95% CI, –22.6% to 53.6%), and for non-Asian subjects, it remained –6.9% (95% CI, –43.4% to 29.6%).

In a study analyzing patients who received at least one dose of either SB12 or eculizumab, 53% were Asian and 47% were non-Asian. Treatment-emergent adverse events (TEAEs) were observed in 84.6% of Asians and 87% of non-Asians, with both subgroups experiencing similar incidence and safety profiles between SB12 and eculizumab, and most TEAEs being mild, moderate, and transient.

Despite these comparable safety profiles, the current modest price difference between SB12 and reference eculizumab limits its potential to significantly improve treatment accessibility in low-income countries, highlighting the need for further cost reduction in manufacturing and distribution to enhance access to this vital therapy.

“The safety profiles were also comparable between SB12 and ECU-treated patients by race subgroup (Asians and non-Asians), supporting the clinical use of SB12 for the treatment of PNH patients globally,” study authors concluded.

Jang JH, Tomuleasa C, Oliynyk H, et al. Epysqli (SB12; biosimilar to reference eculizumab) in Asian and non-Asian patients with paroxysmal nocturnal hemoglobinuria: subgroup analysis of a global phase III randomized controlled trial. 

. 2025;6(2):e70020. Published 2025 Mar 21. doi:10.1002/jha2.70020

Paroxysmal nocturnal hemoglobinuria (PNH): symptoms & treatment. Cleveland Clinic. April 25, 2022. Accessed July 1, 2025. 

https://my.clevelandclinic.org/health/diseases/22871-paroxysmal-nocturnal-hemoglobinuria

Jeremias S. FDA approves Epysqli as second Soliris biosimilar. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/fda-approves-epysqli-as-second-soliris-biosimilar

Articles

Biosimilar SB12 demonstrated comparable efficacy and safety for paroxysmal nocturnal hemoglobinuria (PNH) to its reference drug, showing similar outcomes across diverse patient groups.

Biosimilar SB12 Matches Eculizumab in PNH Treatment Across Diverse Patient Groups

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

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

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


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

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

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

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

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

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

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

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


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


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

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

Expert Insights on Overcoming Patient Education Gaps, Biosimilar Financial Hurdles

Here are the top 5 biosimilar articles for the week of June 23, 2025.

: Explore how real-world evidence and biosimilars 

, improving diabetes care and outcomes for patients who have type 2 diabetes.

: The new data were collected to fulfill the FDA's requirements to designate adalimumab-fkjp (Hulio) as 

, enhancing access to affordable biologics for chronic plaque psoriasis treatment.

: Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans 

, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.

, administered via autoinjector, offers comparable efficacy and a consistent safety profile to reference tocilizumab in patients with rheumatoid arthritis.

 enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.

The Top 5 Biosimilar Articles for the Week of June 23

Here are the top 5 biosimilar articles for the week of June 16, 2025.

: The new data were collected to fulfill the 

 to designate adalimumab-fkjp (Hulio) as interchangeable with Humira, enhancing access to affordable biologics for chronic plaque psoriasis treatment.

 of adalimumab biosimilars in treating inflammatory diseases.

: The biosimilar industry faces awareness challenges among health care professionals (HCPs), which must be addressed to 

 (IBD) show high acceptance of adalimumab biosimilars, achieving positive outcomes and clinical remission after switching.

: Leading biosimilar companies Sandoz, STADA Arzneimittel, and Samsung Bioepis report 

, driven by strong denosumab biosimilars and expanding portfolios.

The Top 5 Biosimilars Articles for the Week of June 16

Tocilizumab biosimilar CT-P47, administered via autoinjector, offers comparable efficacy and a consistent safety profile to reference tocilizumab in patients with rheumatoid arthritis. | Image Credit: yodiyim - stock.adobe.com

Patients with moderate-to-severe rheumatoid arthritis demonstrated a successfully usable and effective self-administration option of the tocilizumab biosimilar CT-P47, delivered through an autoinjector, further solidifying the role of biosimilars as a critical component in expanding access and managing the economic burden of chronic disease, according to a study published in 

The IL-6 pathway involves various inflammatory diseases and could potentially target an array of clinical conditions, including rheumatoid arthritis. Both infection and other types of inflammation can induce IL-6 production.

 Macrophages produce IL-6 mainly in response to pathogens or inflammation-related damage-associated molecular patterns. IL-6 also performs a protective function by removing infectious agents and healing damaged tissue through the induction of acute phase and immune responses.

Tocilizumab, a humanized monoclonal antibody, binds to membrane-bound and soluble forms of the IL-6 receptor, inhibiting IL-6 mediated signaling.

Currently, rheumatology treatment guidelines advocate for biosimilars and acknowledge their potential role in reducing the cost burden of biologic therapy.

Based on Q3 2024, tocilizumab biosimilars tocilizumab-bavi (Tofidence; Organon) and tocilizumab-aazg (Tyenne; Fresenius Kabi) launched with wholesale acquisition cost discounts of 16% and 26%, respectively.

 Tocilizumab-aazg's 35% average sales price discount compared with the originator is creating modest growth toward tocilizumab-bavi.

Researchers conducted a single-arm, open-label, multiple-dose phase 3 study (NCT05725434) that evaluated the usability of the CT-P47 autoinjector, along with its efficacy, safety, and immunogenicity among patients with moderate-to-severe rheumatoid arthritis.

 A total of 33 patients received CT-P47, but only 87.9% completed the entire study. Most patients were White women (72.7%) with a median of 4.8 years since their official diagnosis.

The study met its primary end point when scores for all post–Self-Injection Assessment Questionnaire domains at week 2 exceeded 8, except for "self-confidence" (7.11) and "satisfaction with self-injection" (7.98). Overall, the "pain and skin reaction during or after the injection" domain received the highest mean score (9.62). Patients generally felt confident about self-injection prior to their first administration of the study drug. All patients in the usability set successfully followed the self-injection assessment checklist.

Researchers observed a decrease in the mean Disease Activity Score in 28 joints (DAS28) for C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) scores from baseline to week 12. At week 12, standard deviation changes from baseline measured −2.810 and −3.659, respectively. By week 12, mean values for CRP and ESR reached 1.416 and 8.4, respectively, a reduction from baseline values of 5.487 and 35.7.

No one reported autoinjector malfunctions throughout the study. Researchers observed 22 treatment-emergent adverse events (TEAEs) in 36.4% of patients, and 36.4% of these patients experienced drug-related TEAEs. Only 2 patients had TEAEs that led to study drug discontinuation: 1 participant developed a cerebrovascular disorder and the other developed Grade 1 erythema. Researchers considered both possibly related to the study drug.

Leukopenia, neutropenia, and injection site reactions were the most common TEAEs, each affecting 9.1% of patients. Most TEAEs were Grade 1 or 2 in intensity and resolved during the study. Some patients had Grade 3 TEAEs (12.1%) but no TEAEs were Grade 4 or 5 in intensity, and researchers observed no new safety signals.

This 12 week study has limitations, including the small, predominantly female, and exclusively White cohort that may impact generalizability, even though female prevalence mirrors typical rheumatoid arthritis populations. Selection bias is also possible, as we included only patients comfortable with self-injections. The absence of a placebo control further limits definitive conclusions on CT-P47 SC safety and efficacy. However, long-term phase 3 data for CT-P47 intravenous injection (NCT05489224) demonstrates efficacy and safety comparable with reference tocilizumab. This provides supportive evidence for CT-P47 subcutaneous, though post-marketing surveillance will be essential to confirm its long-term profile.

“Repeated subcutaneous dosing through week 12 was associated with improvements in efficacy parameters and a safety profile consistent with reference tocilizumab,” concluded study authors.

Burmester G, Klimiuk PA, Trefler J, et al. Usability, efficacy, and safety of candidate tocilizumab biosimilar CT-P47 self-administration via auto-injector and pre-filled syringe in patients with rheumatoid arthritis: a single-arm, open-label, phase 3 study. 

. 2025;21(4):521-529. doi:10.1080/1744666x.2025.2451215

Pandolfi F, Franza L, Carusi V, Altamura S, Andriollo G, Nucera E. Interleukin-6 in rheumatoid arthritis. 

. 2020;21(15):5238. Published July 23, 2020. doi:10.3390/ijms21155238

Jeremias S. Biosimilars drive cost savings and achieve 53% market share across treatment areas. The Center for Biosimilars

. January 16, 2025. Accessed June 18, 2025. 

https://www.centerforbiosimilars.com/view/biosimilars-drive-cost-savings-and-achieve-53-market-share-across-treatment-areas

Tocilizumab biosimilar CT-P47, administered via autoinjector, offers comparable efficacy and a consistent safety profile to reference tocilizumab in patients with rheumatoid arthritis.

Tocilizumab Biosimilar CT-P47 Shows Promise for Rheumatoid Arthritis Self-Administration

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.


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

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

: Leading biosimilar companies Sandoz, STADA Arzneimittel, and Samsung Bioepis 

lower development costs and streamlined regulations

 to enhance patient access to affordable biosimilars.

 launch in the US, enhancing access to affordable treatments for osteoporosis and cancer-related skeletal events.

 accelerate the entry of generics and biosimilars, saving the health care system $422.9 billion and enhancing drug accessibility.

 matches Prolia in efficacy, offering a cost-effective treatment option for postmenopausal osteoporosis.

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. | Image Credit: SNAB - stock.adobe.com

(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.

Biosimilar FYB202 Shows Therapeutic Equivalence to Ustekinumab for Plaque Psoriasis

Here are the top 5 biosimilar articles for the week of June 2, 2025.

 for new biosimilars like Starjemza and Hadlima enhance treatment options, addressing urgent needs for affordability and policy reform.

: Denosumab biosimilars Wyost and Jubbonti launch in the US, enhancing access to affordable treatments for 

osteoporosis and cancer-related skeletal events

FDA designates 2 biosimilars as interchangeable

, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.

, enhancing treatment options for rheumatic and gastrointestinal conditions.