Biocon Biologics has received Health Canada approval for Yesintek™ (ustekinumab injection) and Yesintek™ I.V., biosimilars to Stelara®. This approval, granted on October 17, 2025, allows for the treatment of moderate to severe plaque psoriasis in adults and children, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Yesintek will be available through the My Biocon Biologics™ patient support program.
Canadian Approval for Biosimilar
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), biosimilars to Stelara®. The approval was granted on October 17, paving the way for commercial availability.
Therapeutic Indications
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, moderately to severely active Crohn’s disease, and ulcerative colitis in adults.
Clinical Data and Availability
Health Canada’s approval was based on data confirming that YESINTEK is highly similar to Stelara, with no clinically meaningful differences in efficacy, safety, and immunogenicity. YESINTEK will be available through the My Biocon Biologics™ patient support program. It is available as a subcutaneous injection (45 mg/0.5ml and 90 mg/ml) and as an intravenous solution (130 mg/26mL).
Executive Commentary
Shreehas Tambe, CEO & Managing Director, Biocon Biologics, said: “Health Canada’s approval of Yesintek™ marks a significant milestone in our mission to expand global access to high-quality biosimilars. Building on our successful U.S. launch, this approval strengthens our presence in North America and enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions.”
Ramy Ayad, Head of Canada at Biocon Biologics, said: “We are excited to bring Yesintek™ to Canadian patients, providing a trusted, value-driven ustekinumab biosimilar. Biocon Biologics is committed to advancing biosimilar adoption in Canada to improve outcomes for patients and deliver meaningful savings to the healthcare ecosystem.”
About YESINTEK
YESINTEK (ustekinumab injection) and YESINTEK I.V. (ustekinumab for injection, solution for intravenous infusion) are biosimilars to STELARA and STELARA I.V.
Source: BSE
