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Biocon Receives Health Canada Approval for Yesintek® (ustekinumab) Autoinjector Pen

  • Posted by: BIOCON

NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, July 29, 2026

Biocon Limited’s subsidiary in Canada has received Notice of Compliance (NOC) approval for Yesintek® (ustekinumab) Autoinjector 45 mg/0.05 mL and 90 mg/mL from Health Canada. Health Canada previously granted Notice of Compliance for Yesintek® (solution for subcutaneous injection) 45 mg/0.5ml (prefilled syringe and vial) and 90mg/ml (prefilled syringe) and Yesintek® I.V. (solution for intravenous infusion) 130 mg/26 mL (5mg/mL) in October 2025.

The availability of the Yesintek® Autoinjector provides patients with an option that the originator product does not offer in Canada. The new format will allow customized treatment approaches across care settings and patient needs.

Yesintek® is indicated for the treatment of moderate to severe plaque psoriasis in adult patients and in pediatric patients (6-17 years of age), active psoriatic arthritis in adults, moderately to severely active Crohn’s disease and ulcerative colitis in adults—a range of debilitating autoimmune conditions that affect thousands of Canadians.

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.

– Company Spokesperson

Author: BIOCON
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