365telugu.com online news, october 23rd,2025: Biocon Biologics Ltd (BBL), a global leader in biosimilars and a subsidiary of Biocon Ltd (BSE: 532523, NSE: BIOCON), announced on October 23, 2025, that Health Canada has issued a Notice of Compliance (NOC) for Yesintek™ (ustekinumab injection) and Yesintek™ I.V. (ustekinumab for intravenous infusion), biosimilars to Stelara® and Stelara® I.V. The approval, granted on October 17, enables commercial availability in Canada from mid-October.
Yesintek™ and Yesintek™ I.V. are approved for treating moderate to severe plaque psoriasis in adults and pediatric patients (6-17 years), active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults, addressing critical autoimmune conditions affecting many Canadians.
The approval was supported by a robust data package demonstrating that Yesintek™ is highly similar to Stelara®, with no significant differences in efficacy, safety, or immunogenicity.
Yesintek™ will be accessible through the My Biocon Biologics™ patient support program, offering assistance to patients. It is available as subcutaneous injections (45 mg/0.5ml in prefilled syringe and vial, 90 mg/ml in prefilled syringe) and as an intravenous solution (130 mg/26mL, 5mg/mL).
Shreehas Tambe, CEO & Managing Director of Biocon Biologics, stated: “The approval of Yesintek™ by Health Canada is a key milestone in our commitment to providing high-quality biosimilars globally.
Following our successful U.S. launch, this approval bolsters our North American presence and enriches our immunology portfolio, offering a cost-effective treatment for Canadian patients with chronic autoimmune diseases.”
Ramy Ayad, Head of Canada at Biocon Biologics, added: “We are thrilled to introduce Yesintek™ to Canadian patients, delivering a reliable, value-driven ustekinumab biosimilar.
Biocon Biologics is dedicated to promoting biosimilar adoption in Canada to enhance patient outcomes and generate significant healthcare savings, fostering a sustainable biosimilars ecosystem for all Canadians.”