Date: July 29, 2026
Product Approval Disclosure
Biocon Limited's subsidiary in Canada has received Notice of Compliance (NOC) approval from Health Canada for Yesintek® (ustekinumab) Autoinjector in two formulations: 45 mg/0.05 mL and 90 mg/mL.
This approval follows Health Canada's previous NOC grant in October 2025 for Yesintek® solution for subcutaneous injection (45 mg/0.5ml in prefilled syringe and vial, 90 mg/ml in prefilled syringe) and Yesintek® I.V. solution for intravenous infusion (130 mg/26 mL at 5mg/mL concentration).
Product Significance and Differentiation
The autoinjector format provides patients with a treatment option that the originator product does not currently offer in the Canadian market. This new delivery format will allow for customized treatment approaches across different care settings and patient needs.
Therapeutic Indications
Yesintek® is indicated for the treatment of:
- Moderate to severe plaque psoriasis in adult patients
- Moderate to severe plaque psoriasis in pediatric patients (6-17 years of age)
- Active psoriatic arthritis in adults
- Moderately to severely active Crohn's disease in adults
- Moderately to severely active ulcerative colitis in adults
These conditions represent a range of debilitating autoimmune diseases that affect thousands of Canadian patients.
Strategic Impact
This approval further strengthens Biocon's portfolio of immunology products in Canada and reaffirms the company's commitment to increasing patient access to affordable medicines around the world.