Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek™ (ustekinumab injection) and Yesintek™ I.V., a biosimilar to Stelara® (ustekinumab injection) and Stelara® I.V. (ustekinumab for injection, solution for intravenous infusion). The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October.
ESINTEK and YESINTEK I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age), active psoriatic arthritis in adults, moderately to severely active Crohn’s disease and ulcerative colitis in adults—a range of debilitating autoimmune conditions that affect thousands of Canadians.
YESINTEK (ustekinumab injection) and YESINTEK I.V. (ustekinumab for injection, solution for intravenous infusion) is a biosimilar to STELARA and STELARA I.V., a fully human IgG1қ monoclonal antibody, a first-in-class agent that binds with specificity to the shared p40 protein subunit of human cytokines interleukin IL-12 and IL-23 mediated signaling associated with immune-mediated diseases. The Phase 3 STELLAR-2 study demonstrated no clinically meaningful differences between YESINTEK and STELARA in terms of pharmacokinetics, efficacy, safety, and immunogenicity.
Health Canada approval was based on a comprehensive data package, confirming that YESINTEK is highly similar to Stelara with no clinically meaningful differences in efficacy, safety and immunogenicity. YESINTEK is available as a subcutaneous injection, 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and YESINTEK I.V. as an intravenous solution, 130 mg/26mL (5mg/mL).
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. By expanding access in both public and private markets, we aim to help build a sustainable biosimilars industry that benefits all Canadians.”
