Promising Results for Ustekinumab, Adalimumab Biosimilars Presented at AAD

Biocon’s ustekinumab biosimilar demonstrated comparable efficacy and safety to reference ustekinumab, while CT-P17 was confirmed as interchangeable with adalimumab, according to 2 posters presented at the American Academy of Dermatology meeting.

The American Academy of Dermatology held its annual meeting from March 7 to 11, 2025, at the Orange County Convention Center in Orlando, Florida. | Image credit: fusssergei - stock.adobe.com

Biocon’s proposed biosimilar ustekinumab (Bmab-1200; Yesintek) demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics compared with reference ustekinumab in adults with moderate to severe chronic plaque psoriasis, according to the first poster.¹

So far in 2025, 6 ustekinumab biosimilars referencing Stelara have launched on the US market, including Yesintek (ustekinumab-kfce).² The present randomized, double-blind, parallel group, multicenter, phase 3 study was designed as a comparative efficacy study to determine whether Yesintek is a clinically comparative alternative to the ustekinumab reference product.

Overall, researchers enrolled 384 patients with plaque psoriasis (male, n = 257) who had confirmed plaque psoriasis for at least 6 months that affects at least 10% of their body surface area. Patients also have to have a Psoriasis Area and Severity Index (PASI) score of 12 or higher and a static Physician’s Global Assessment (sPGA) score of 3 or higher at screening and baseline.

The study included a 4-week screening period followed by a 52-week double-blind, active-controlled treatment phase. In the first treatment period (TP1), patients received either the biosimilar or reference ustekinumab from baseline to week 16. In TP2 (week 16 to week 28), patients who achieved a PASI 50 response or greater were rerandomized, with some switching from ustekinumab to the biosimilar. Those who completed TP2 and achieved at least a PASI 75 response at week 28 entered TP3, continuing treatment through week 52.

The primary efficacy endpoint was the percentage change from baseline (%CFB) in PASI score at Week 12. Results showed that Bmab-1200 demonstrated equivalent efficacy to ustekinumab, with a least squares (LS) mean %CFB PASI score of −79.87% in the biosimilar group and −80.55% in the originator group.

Secondary efficacy end points, including those assessed after switching from ustekinumab to the biosimilar, were similar between the treatment groups. Overall, the study demonstrated that Bmab-1200 has comparable safety and efficacy profiles to reference ustekinumab, supporting its potential as a Stelara treatment alternative.

CT-P17 is interchangeable with reference adalimumab, as repeated switching between the two showed comparable pharmacokinetics, efficacy, safety, and immunogenicity up to week 52, according to another poster.³

During the randomized, active-controlled, double-blind, multicenter, phase 3 study, patients with moderate to severe plaque psoriasis initially received a dose of reference adalimumab (Humira) 80 mg, followed by 40 mg every other week, starting 1 week after the initial dose.

At week 13, patients were randomized into 2 groups: the switching group (n = 172), which underwent repeated transitions between adalimumab and CT-P17, and the Humira maintenance group (n = 174), which continued on adalimumab until week 27. After week 27, all patients received CT-P17 as open-label treatment until week 49 and were monitored through week 52. Over 60% of patients in both groups were men, and 100% of the cohort was White. The mean age was 42 years in the switching group and 44 in the Humira group.

Serum drug concentrations remained similar between the switching and Humira maintenance groups throughout the study. By Week 52, the mean PASI score improvement was 90.59% in the switching group and 90.10% in the ADA maintenance group.

The proportions of patients achieving PASI 50/75/90/100 responses and those with an sPGA score of 0 or 1 were also comparable between groups. In terms of safety, a total of 634 treatment-emergent adverse events (TEAEs) were reported, affecting 68.0% of patients in the switching group and 65.9% in the reference product maintenance group.

Switching between Humira and CT-P17 was well tolerated, with no notable differences in safety or immunogenicity. Importantly, no increased immunogenicity or safety concerns were observed following multiple switches up to week 52.

References

1. Wolf-Holz E, Szepietowski J, Reich A. Randomized, double-blind, parallel group, multicenter, phase 3 study to demonstrate equivalent efficacy and to assess safety, immunogenicity, and pharmacokinetics of BMAb-1200 compared to reference ustekinumab in adult subjects with moderate to severe chronic plaque psoriasis. Presented at: AAD annual meeting; March 7-11, 2025; Orlando, FL. Poster 60667.

2. Jeremias S. 3 ustekinumab biosimilars launch on US market. The Center for Biosimilars^®. February 24, 2025. Accessed March 18, 2025. https://www.centerforbiosimilars.com/view/3-ustekinumab-biosimilars-launch-on-us-market

3. Lebwohl M, Paiser D, Koo J, et al. Pharmacokinetics, efficacy and safety after multiple switches from reference adalimumab to adalimumab biosimilar (CT-P17) in comparison with the maintenance group (reference adalimumab) in patients with moderate-to-severe plaque psoriasis: week 52 results from the phase III interchangeability study. Presented at: AAD annual meeting; March 7-11, 2025; Orlando, FL. Poster 59550.