Biocon Biologics has received Health Canada approval for Yesintek (ustekinumab injection) and Yesintek I.V. (ustekinumab for injection, solution for intravenous infusion) — biosimilars to Stelara and Stelara I.V., respectively. The regulatory clearance was granted on October 17, paving the way for commercial availability in Canada by mid-October.
The approval is based on a comprehensive analytical, preclinical, and clinical data package, confirming that Yesintek is highly similar to Stelara, with no clinically meaningful differences in efficacy, safety, or immunogenicity.
Yesintek and Yesintek I.V. are approved for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients (6–17 years), as well as active psoriatic arthritis, moderately to severely active Crohn’s disease, and ulcerative colitis in adults — a group of chronic autoimmune diseases that affect thousands of Canadians.
“Health Canada's approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars,” said Shreehas Tambe, CEO & Managing Director, Biocon Biologics. “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.”
Biocon Biologics, a global biopharmaceutical company, continues to advance its mission of improving affordable access to biologic therapies for chronic conditions, including diabetes, cancer, and autoimmune diseases.
