“Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), today 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 company said in an exchange filing.
The study confirmed that YESINTEK matches Stelara (Ustekinumab) in effectiveness, safety, immune response, and drug behavior in the body. This marks a major step for Biocon Biologics in making biosimilar therapies more accessible globally.
The study found that YESINTEK and Stelara (Ustekinumab) had equivalent effectiveness in treating psoriasis. At Week 12, both treatments showed similar improvements in Psoriasis Area and Severity Index (PASI) scores, with a mean difference of just 0.68%, within the equivalence limits set by the U.S. FDA and EMA. Additionally, YESINTEK’s safety profile matched that of Stelara throughout the study.
“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,” said Elena Wolff-Holz, M.D., Global Head Clinical Development at Biocon Biologics.
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Biocon share price performance
Over the past year, the shares of Biocon increased by 18.31%. Year-to-date (YTD) the stock has declined by 9.59%. Over the last six months, there has been a 10.84% decrease, while the three-month period saw a 12.23% drop. In the past month, the price fell by 13.70%.On Friday, the shares of Biocon closed flat at Rs 333.45 on the BSE.
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