YESINTEK and YESINTEK IV are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age)
Biocon Biologics announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek (ustekinumab injection) and Yesintek IV (ustekinumab for injection, solution for intravenous infusion), a biosimilar to Stelara (ustekinumab injection) and Stelara IV (ustekinumab for injection, solution for intravenous infusion).
The approval paved the way for Canadian commercial availability in mid-October. YESINTEK and YESINTEK IV are indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in paediatric 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.
Shreehas Tambe, CEO and 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, 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.”
