Biocon Biologics Ltd (BBL), a global biosimilars company and a subsidiary of Biocon Ltd (BSE: 532523, NSE: BIOCON), has announced that Health Canada has granted a Notice of Compliance (NOC) for its ustekinumab biosimilar, Yesintek™ (ustekinumab injection) and Yesintek™ I.V. (ustekinumab for injection, solution for intravenous infusion). The regulatory approval, issued on October 17, 2025, clears the way for the product’s commercial launch in Canada by mid-October.
Yesintek is a biosimilar to Stelara® (ustekinumab), used for treating a range of serious autoimmune disorders. Health Canada’s approval covers indications for moderate to severe plaque psoriasis in adults and children (aged 6–17 years), active psoriatic arthritis in adults, and moderately to severely active Crohn’s disease and ulcerative colitis in adults.
According to Biocon Biologics, the approval was based on a comprehensive data package that demonstrated Yesintek’s high similarity to the reference biologic Stelara, showing no clinically meaningful differences in efficacy, safety, or immunogenicity.
The therapy will be made available in Canada through the My Biocon Biologics™ patient support program, which assists patients prescribed with Biocon’s biosimilars.
Yesintek will be available in the following formulations:
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Subcutaneous injection: 45 mg/0.5 mL (prefilled syringe and vial) and 90 mg/mL (prefilled syringe)
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Intravenous infusion: 130 mg/26 mL (5 mg/mL) under the brand Yesintek I.V.
This approval strengthens Biocon Biologics’ presence in North America’s biosimilars market and marks another milestone in the company’s global mission to make advanced biologic therapies more accessible and affordable.
