Biocon's Yesintek® Autoinjector Pen Receives Health Canada Approval
Biocon's subsidiary in Canada received Health Canada approval for Yesintek® (ustekinumab) Autoinjector. This new format offers patients an additional treatment option for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The approval strengthens Biocon's immunology portfolio in Canada.
The approval of a new autoinjector pen for Yesintek® expands Biocon's product offerings in Canada and could lead to increased market penetration in the immunology segment. While positive, the direct financial impact in the short term is not explicitly quantified.
The approval of a new drug delivery format by a major regulatory body like Health Canada is a positive development for the company, indicating product innovation and market expansion.
Biocon Limited announced that its subsidiary in Canada has received a Notice of Compliance (NOC) approval from Health Canada for Yesintek® (ustekinumab) Autoinjector 45 mg/0.05 mL and 90 mg/mL. This approval follows Health Canada's earlier NOC in October 2025 for Yesintek® in prefilled syringe and vial formats, as well as for its intravenous infusion.
The Yesintek® Autoinjector offers a new treatment option in Canada, complementing the originator product and allowing for tailored treatment approaches across different care settings and patient needs. Yesintek® is indicated for moderate to severe plaque psoriasis in adults and pediatric patients (6-17 years), active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults.
This approval is expected to bolster Biocon's immunology product portfolio in Canada and underscores the company's commitment to enhancing global patient access to affordable medicines.
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