Phase 3 study comparing Yesintek with Stelara in adult patients with chronic plaque psoriasis shows positive results: Biocon Biologics

Bengaluru: BioconBiologics Ltd., a fully integrated global biosimilars company and subsidiary of Biocon Ltd. has announced the successful results of a pivotal Phase 3, randomized, double-blind, parallel group, multicenter study comparing Yesintek (Biocon Biologics’ biosimilar to Ustekinumab, called YESINTEK) with reference product Stelara (Ustekinumab) in adult patients with moderate to severe chronic plaque psoriasis (PsO).

The data are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara (Ustekinumab).

Elena Wolff-Holz, M.D., Global Head Clinical Development, Biocon Biologics said, “The positive results from this Phase 3 study reaffirm the quality and therapeutic equivalence of YESINTEK compared to reference product Ustekinumab. This milestone underscores our commitment to providing cost-effective, high-quality biosimilars to patients with chronic conditions like psoriasis, expanding access to critical treatments globally.”

The primary efficacy endpoint, percentage change from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12, demonstrated that YESINTEK was equivalent to reference Stelara (Ustekinumab), with both treatments showing similar improvement in PASI scores. The mean difference between the two groups was 0.68%, falling within the predefined equivalence margins for both the U.S. Food and Drug Administration (U.S. FDA) and European Medicines Agency (EMA).

The safety profile of YESINTEK was similar to the reference product Stelara (Ustekinumab) through the duration of the study. The pharmacokinetic and immunogenicity profiles of YESINTEK were found to be similar to those of reference Stelara (Ustekinumab), with no significant differences in efficacy or safety outcomes between the two treatments. Additionally, the study assessed the impact of switching from reference Stelara (Ustekinumab) to YESINTEK at Week 16, with results showing continued efficacy and safety through Week 52.

Uwe Gudat, M.D., Chief Medical Officer, Biocon Biologics said, “The results from this study show convincingly once more that in-vitro analytical comparability translates well into in-vivo clinical performance. The study reinforces the confidence we can have in the biosimilar regulatory pathways and the principles they are built on. Specifically, for YESINTEK the study shows that it offers an effective, safe, and comparable alternative to reference Ustekinumab in the treatment of moderate to severe chronic plaque psoriasis and by extension the other indications for which Ustekinumab is indicated. YESINTEK is another important addition to our portfolio of affordable biologics that promise improved patient care by providing a cost-effective treatment option without compromising clinical outcomes.”

The study is being presented as:

Poster Title: 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

Authors: Elena Wolff-Holz, Jacek Szepietowski, Adam Reich, Steven Feldman, Grazyna Pulka, Lally Mekokishvili, Gursharan Singh, Sarika Deodhar, Subramanian Loganathan, Ashwani Marwah, and Sandeep Athalye

Category: Psoriasis & Other Papulosquamous Disorders

Date/Time: 8:00am EDT, March 7, 2025