Biocon‘s Canadian subsidiary has received a Notice of Compliance (NOC) from Health Canada for Yesintek (ustekinumab) Autoinjector in 45 mg/0.5 mL and 90 mg/mL strengths.
The approval expands the company’s biosimilar portfolio in Canada and adds a new administration option for patients with autoimmune diseases.
Biocon expands immunology presence in Canada
Biocon said the latest approval further strengthens its immunology portfolio in Canada and supports its strategy of expanding access to affordable biosimilar medicines globally.
The company added that the approval reinforces its commitment to improving patient access to cost-effective treatment options for people living with autoimmune diseases.
About Yesintek autoinjector: A new treatment option
Biocon said the Yesintek autoinjector gives patients an option that the originator product is currently not available in Canada. The company said the new delivery format will support more personalized treatment across different care settings and better address patient needs.
Health Canada had earlier granted Notice of Compliance for Yesintek prefilled syringe, vial, and intravenous infusion formulations in October 2025.
Yesintek is approved for the treatment of moderate to severe plaque psoriasis in adults and children aged 6 to 17 years. It is also indicated for active psoriatic arthritis in adults, as well as moderately to severely active Crohn’s disease and ulcerative colitis in adults.
These are chronic autoimmune conditions that affect thousands of people in Canada.
About Biocon
Biocon, founded in 1978 and headquartered in Bengaluru, is a global biopharmaceutical company focused on developing affordable medicines for patients worldwide. The company operates across four key businesses—generics, biosimilars, novel biologics and research services—and has a presence in more than 120 countries.
Biocon develops and manufactures therapies for diabetes, cancer and autoimmune diseases, with an integrated business model spanning research and development, manufacturing and commercialization.
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