Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., has received an approval from Health Canada for chronic autoimmune conditions treatment medications Yesintek and Yesintek IV.

The notice of compliance (NOC) granted by Health Canada is for Yesintek (ustekinumab injection) and Yesintek IV (ustekinumab for injection, solution for intravenous infusion), biosimilars to Stelara (ustekinumab injection) and Stelara I.V. (ustekinumab for injection, solution for intravenous infusion).

The approval, granted on October 17, 2025, paves the way for commercial availability in Canada beginning mid-October.

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, said: “Health Canada’s approval of Yesintek marks another important milestone in our mission to expand global access to high-quality biosimilars. Building on our successful U.S. launch, this approval strengthens our North American presence and further enhances our immunology portfolio, offering a more affordable treatment option for patients living with chronic autoimmune diseases.”

Yesintek and Yesintek I.V. are approved for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6–17 years of age), active psoriatic arthritis in adults, as well as moderately to severely active Crohn’s disease and ulcerative colitis in adults—a range of chronic autoimmune conditions that significantly impact the lives of thousands of Canadians.

Yesintek will be available through the My Biocon Biologics patient support program, designed to assist individuals prescribed the therapy. The product will be offered as a subcutaneous injection (45 mg/0.5 mL prefilled syringe and vial; 90 mg/mL prefilled syringe) and as an intravenous solution (130 mg/26 mL, 5 mg/mL).