Toronto/Bengaluru, October 23, 2025: Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd., has received Health Canada’s Notice of Compliance for Yesintek™ (ustekinumab injection) and Yesintek™ I.V., biosimilars to Stelara® and Stelara® I.V.
Approved on October 17, 2025, Yesintek will be commercially available in Canada by mid-October. The therapies are indicated for moderate to severe plaque psoriasis (adults and children 6–17 years), active psoriatic arthritis (adults), and moderately to severely active Crohn’s disease and ulcerative colitis (adults).
Health Canada’s decision followed a comprehensive review confirming comparable efficacy, safety, and immunogenicity with the reference product. Yesintek will be accessible via the My Biocon Biologics™ patient support program and offered in subcutaneous (45 mg/0.5 ml, 90 mg/ml) and intravenous (130 mg/26 ml) formulations.
Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said the approval underscores the company’s commitment to making advanced biologics affordable and expanding its North American footprint.
Ramy Ayad, Head of Canada, Biocon Biologics, added that Yesintek™ will enhance patient access to value-driven biosimilars while contributing to healthcare cost efficiency in Canada.
