Biocon Ltd has announced that its Canadian subsidiary has received Health Canada’s Notice of Compliance (NOC) for Yesintek® (ustekinumab) Autoinjector in 45 mg/0.5 mL and 90 mg/mL strengths.
The approval expands Biocon's immunology portfolio in Canada, following the regulatory clearance granted in October 2025 for Yesintek® prefilled syringes, vials, and intravenous infusion formulations.
The newly approved autoinjector offers Canadian patients a self-administration option that is not available with the originator product, enabling more personalized treatment across different care settings.
Yesintek® is indicated for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, providing an affordable treatment option for patients with chronic autoimmune disorders. Biocon said the approval reinforces its commitment to expanding global access to high-quality and affordable biosimilar medicines.