Biocon Expands Canadian Immunology Portfolio with Health Canada Approval for Yesintek Autoinjector

Biocon has strengthened its presence in the Canadian biosimilars market after its Canadian subsidiary received Health Canada approval for the Yesintek (ustekinumab) Autoinjector in 45 mg/0.5 mL and 90 mg/mL formulations on July 29. This approval follows the regulatory clearance received in October 2025 for Yesintek in prefilled syringe, vial and intravenous infusion formats. The autoinjector provides Canadian patients with an additional treatment option that is not available with the originator product, offering greater convenience and supporting more personalised treatment across different healthcare settings. Yesintek is approved for the treatment of moderate to severe plaque psoriasis in adults and children aged 6–17 years, active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults. The latest approval further strengthens Biocon’s immunology portfolio in Canada and aligns with its strategy of improving access to affordable medicines globally. Separately, the company also received approval from the European Medicines Agency (EMA) earlier this month for a new fill-finish line for Semglee (insulin glargine) at its insulin manufacturing facility in Malaysia, with commercial supplies to Europe expected to begin in Q2 FY27, highlighting Biocon’s continued focus on expanding its global manufacturing and product capabilities. $BIOCON Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.