Biotechnology firm Bonon Ltd on Friday (March 7) said its subsidiary Biocon Biologics Ltd has announced positive results from its phase 3 clinical trial for Yesintek, a biosimilar to ustekinumab (marketed as Stelara).
The randomised, double-blind, parallel-group, multi-centre study evaluated Yesintek in adult patients with moderate to severe chronic plaque psoriasis (PsO). The findings, which confirm the biosimilar’s efficacy and safety profile compared to Stelara, 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, marking a significant milestone for Biocon Biologics in advancing the accessibility of biosimilar therapies for patients worldwide.
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Elena Wolff-Holz, 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.
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The mean difference between the two groups was 0.68%, falling within the predefined equivalence margins for both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The safety profile of Yesintek was similar to the reference product Stelara through the duration of the study.
The pharmacokinetic and immunogenicity profiles of Yesintek were found to be similar to those of the reference Stelara, with no significant differences in efficacy or safety outcomes between the two treatments.
Additionally, the study assessed the impact of switching from reference Stelara to Yesintek at week 16, with results showing continued efficacy and safety through week 52.
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Uwe Gudat, 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.”
Shares of Biocon Ltd ended at ₹333.45, up by ₹0.35, or 0.11%, on the BSE.
