Biocon Biologics Ltd, a global biosimilars company, has announced that Health Canada has granted approval for Yesintek, a biosimilar to Stelara, for the treatment of several moderate to severe autoimmune diseases. The approval includes both subcutaneous and intravenous formulations of the drug, which will be available in Canada by mid-October. Yesintek has been shown to be highly similar to Stelara, with no clinically meaningful differences in efficacy, safety, or immunogenicity.
The approval is a significant step in Biocon Biologics’ mission to expand access to advanced biologic therapies across North America. Yesintek will be used to treat conditions such as plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis, which affect thousands of Canadians. The arrival of an affordable biosimilar option is a welcome development for patients and healthcare providers alike.
The approval of Yesintek is based on a comprehensive data package that demonstrates its similarity to Stelara. The drug will be made available through the My Biocon Biologics Patient Support Program, which provides tailored assistance to patients prescribed the therapy. The program ensures smooth access and ongoing support for patients.
The available formulations of Yesintek include a subcutaneous injection and an intravenous solution. The approval strengthens Biocon Biologics’ global footprint and enhances its immunology portfolio with a more affordable treatment option for Canadian patients. The company remains committed to advancing biosimilar adoption in Canada to improve patient outcomes and deliver meaningful savings to the healthcare system.
With this approval, Biocon Biologics continues to reinforce its leadership in biosimilar innovation and accessibility. The launch of Yesintek in Canada adds to the company’s expanding global footprint and underscores its commitment to making advanced biologic treatments more affordable and widely available. This is a crucial step toward improving patients’ quality of life worldwide. Biocon Biologics’ CEO and Managing Director, Shreehas Tambe, stated that the approval marks a significant milestone in the company’s mission to expand global access to high-quality biosimilars.