Health Canada approves Biocon Biologics' Stelara biosimilar Yesintek
Biocon Biologics Ltd (BBL) announced on October 23, 2025, that Health Canada has granted a Notice of Compliance (NOC) for Yesintek (ustekinumab injection) and Yesintek I.V., a biosimilar to Stelara. This approval, issued on October 17, 2025, paves the way for commercial availability in Canada by mid-October. Yesintek is indicated for treating moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis in adult and pediatric patients.
The approval was based on a comprehensive data package confirming that Yesintek is highly similar to Stelara in efficacy, safety, and immunogenicity. Yesintek will be available in subcutaneous injections (45 mg/0.5ml prefilled syringe and vial; 90 mg/ml prefilled syringe) and as an intravenous solution (130 mg/26mL). This launch follows a successful U.S. launch, strengthening Biocon Biologics' commitment to expanding global access to high-quality and affordable biosimilars.
Shreehas Tambe, chief executive and managing director of Biocon Biologics, highlighted the approval as a significant milestone, while Ramy Ayad, head of Canada, emphasized the company's aim to advance biosimilar adoption and deliver meaningful savings within the Canadian healthcare system. Biocon Biologics aims to transform healthcare by providing affordable access to high-quality biosimilars across over 120 countries.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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