Biocon Biologics Receives Health Canada Approval for Yesintek™ and Yesintek™ I.V., a Biosimilar to Stelara®

Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek™ (ustekinumab injection) and Yesintek™ I.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to Stelara® (ustekinumab injection) and Stelara® I.V. (ustekinumab for injection, solution for intravenous infusion). The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October.

YESINTEK and YESINTEK I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age), active psoriatic arthritis in adults, moderately to severely active Crohn's disease and ulcerative colitis in adults-a range of debilitating autoimmune conditions that affect thousands of Canadians.

Health Canada approval was based on a comprehensive data package, confirming that YESINTEK is highly similar to Stelara with no clinically meaningful differences in efficacy, safety and immunogenicity. YESINTEK will be available through the My Biocon Biologics™ patient support program, which provides assistance to individuals prescribed with the therapy. YESINTEK is available as a subcutaneous injection, 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and YESINTEK I.V. as an intravenous solution, 130 mg/26mL (5mg/mL).

Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said: "Health Canada's approval of Yesintek™ marks a significant milestone in our mission to expand global access to high-quality biosimilars. Building on our successful U.S. launch, this approval strengthens our presence in North America and enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions."

Ramy Ayad, Head of Canada at Biocon Biologics, said: "We are excited to bring Yesintek™ to Canadian patients, providing a trusted, value-driven ustekinumab biosimilar. Biocon Biologics is committed to advancing biosimilar adoption in Canada to improve outcomes for patients and deliver meaningful savings to the healthcare ecosystem. By expanding access in both public and private markets, we aim to help build a sustainable biosimilars industry that benefits all Canadians."

Shares of Biocon Limited was last trading in BSE at Rs. 365.70 as compared to the previous close of Rs. 364.20. The total number of shares traded during the day was 46273 in over 1110 trades.

The stock hit an intraday high of Rs. 367.00 and intraday low of 363.70. The net turnover during the day was Rs. 16910723.00.

Source : Equity Bulls

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