Biocon Limited has announced that its Canadian subsidiary has received a Notice of Compliance (NOC) from Health Canada for the Yesintek® (ustekinumab) Autoinjector Pen. This approval, granted on July 29, 2026, covers the 45 mg/0.05 mL and 90 mg/mL formulations. This new autoinjector format offers patients an alternative treatment option, enhancing Biocon’s immunology portfolio and commitment to accessible medicines.
Biocon Secures Health Canada Approval for Yesintek® Autoinjector Pen
Biocon Limited announced on July 29, 2026, that its subsidiary in Canada has received a Notice of Compliance (NOC) from Health Canada for the Yesintek® (ustekinumab) Autoinjector Pen. The approval specifically covers the 45 mg/0.05 mL and 90 mg/mL formulations.
Expanded Treatment Options
This latest approval complements the previous NOCs granted by Health Canada for Yesintek® (solution for subcutaneous injection) in various strengths and Yesintek® I.V. (solution for intravenous infusion) in October 2025. The availability of the Yesintek® Autoinjector provides Canadian patients with an innovative delivery system that was not previously available from the originator product. This new format is designed to allow for more customized treatment approaches, catering to diverse care settings and individual patient needs.
Therapeutic Indications
Yesintek® is indicated for the treatment of moderate to severe plaque psoriasis in adult and pediatric patients (aged 6-17 years), active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults. These are debilitating autoimmune conditions affecting a significant number of Canadians.
Strengthening Biocon’s Portfolio
This Health Canada approval is a significant development for Biocon, further strengthening its immunology product portfolio within the Canadian market. It underscores the company’s ongoing commitment to expanding patient access to affordable and effective medicines globally.
Source: BSE
