Biocon Gets Health Canada Nod for Yesintek Autoinjector Pen

New Delhi: Biocon Ltd on Wednesday said it has received notice of compliance approval from Canadian health regulator for its Yesintek (ustekinumab) autoinjector, indicated for the treatment of moderate to severe plaque psoriasis.

The company’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, Biocon Ltd said in a regulatory filing.

Health Canada previously granted NOC for Yesintek (solution for subcutaneous injection) 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and Yesintek I.V. (solution for intravenous infusion) 130 mg/26 mL (5mg/mL) in October 2025, it added.

The availability of the Yesintek autoinjector provides patients with an option that the originator product does not offer in Canada, the company said .

The new format will allow customised treatment approaches across care settings and patient needs, it added.

Biocon said 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, a company spokesperson said.

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