Biocon Biologics Reports Promising Phase 3 Results for Yesintek Biosimilar in Psoriasis Treatment

Positive Results for Yesintek™ in Phase 3 Trial

Biocon Biologics Ltd. (BBL), recognized as a prominent global biosimilars company, has recently unveiled encouraging results from its pivotal Phase 3 study of Yesintek™. This biosimilar is designed to align with Ustekinumab, a medication commonly utilized in the treatment of moderate to severe chronic plaque psoriasis (PsO). The outcomes from this extensive study were made public during the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Study Overview

The Phase 3 study was carefully structured as a randomized, double-blind, parallel-group, multicenter trial that aimed to compare the efficacy of Yesintek (known as BMAb-1200) against the reference product Stelara (the branded version of Ustekinumab). This study engaged a sizable cohort of adult patients who presented moderate to severe chronic plaque psoriasis, specifically targeting the effectiveness and safety of Yesintek.

The research findings indicated that Yesintek demonstrated comparable efficacy, safety, immunogenicity, and pharmacokinetics in relation to reference Stelara, marking a pivotal achievement for Biocon Biologics. As emphasized by Elena Wolff-Holz, M.D., the company’s Global Head of Clinical Development, the results highlight Yesintek's capacity to offer a cost-effective and high-quality treatment option for patients afflicted with chronic disorders like psoriasis.

Key Findings

One of the study’s primary endpoints was the percentage change from baseline in the Psoriasis Area and Severity Index (PASI) score at the 12-week mark. The results showcased that Yesintek was equivalent to Stelara, with a mean difference of just 0.68%. This disparity falls neatly within the established equivalence margins set by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Moreover, the safety profile of Yesintek paralleled that of Stelara throughout the study's duration, with no notable safety concerns arising. As part of the clinical assessment, researchers also explored the consequences of switching from Stelara to Yesintek at the 16-week mark. Remarkably, the study found that the transition maintained both efficacy and safety standards well into the extended duration of the assessment at 52 weeks.

In support of these findings, Uwe Gudat, M.D., the Chief Medical Officer at Biocon Biologics, noted, "Our data strongly support that in-vitro analytical comparability translates effectively into in-vivo clinical performance," reinforcing the confidence in biosimilar pathways through rigorous evaluations.

Broader Implications

Yesintek is an important addition to Biocon Biologics’ growing product portfolio, aiming to enhance access to cost-effective biologics for patients across supranational landscapes. This biosimilar targets interleukins IL-12 and IL-23, key contributors to the immune-mediated initiation of psoriasis and various other autoimmune conditions. Additionally, it has received FDA approval for several indications, including treatment of adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, and both Crohn’s disease and ulcerative colitis.

The completion of this Phase 3 trial not only signifies progress in Biocon's biosimilar innovations but also represents the company’s broader commitment to providing patient populations with affordable healthcare solutions and better treatment alternatives. In this respect, Biocon Biologics has successfully commercialized nine biosimilars among its pipeline of 20 products, facilitating enhanced patient care across over 120 countries.

In summary, the promising results from the Phase 3 study of Yesintek are a significant milestone in the biosimilars landscape, as they potentially broaden the therapeutic options available for patients battling chronic plaque psoriasis.

About Biocon Biologics Ltd.

Biocon Biologics Ltd. stands at the forefront of global biosimilars innovation, with a steadfast dedication to transforming healthcare access and outcomes. With an extensive pipeline and a commitment to ensuring affordability in biologics, BBL continues to make strides in delivering effective therapies while advancing sustainability goals.