Biocon Biologics Receives Health Canada Approval for Biosimilar Yesintek™
Biocon Biologics received Health Canada approval for Yesintek™, a biosimilar to Stelara®, for autoimmune conditions. This expands their North American presence with an affordable treatment option.
The regulatory approval and upcoming commercial availability of a new biosimilar in Canada significantly expands Biocon Biologics' market presence and product offering, potentially contributing positively to future sales and market share.
The approval of a biosimilar in a developed market like Canada is a positive development, indicating market expansion, strengthening of the immunology portfolio, and potential for increased revenue.
* Biocon Biologics Ltd (BBL) 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®. * The approval was granted on October 17, 2025, facilitating Canadian commercial availability in mid-October. * Yesintek™ and Yesintek™ I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adult and pediatric patients (6-17 years), active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults. * The approval was based on comprehensive data confirming Yesintek™ is highly similar to Stelara® with no clinically meaningful differences in efficacy, safety, and immunogenicity. * Shreehas Tambe, CEO & Managing Director, Biocon Biologics, highlighted this as a significant milestone, expanding global access to high-quality biosimilars, strengthening their North American presence, and offering an affordable treatment option for Canadian patients. * Ramy Ayad, Head of Canada at Biocon Biologics, expressed excitement about bringing Yesintek™ to Canadian patients, aiming to improve outcomes and deliver savings to the healthcare ecosystem by advancing biosimilar adoption.
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