Biocon Biologics Gets Nod for Yesintek in Canada

Biocon Biologics Ltd (BBL) has reached significant achievement with Health Canada's approval of Yesintek (ustekinumab injection) and Yesintek IV, which are biosimilars of Stelara and Stelara IV.

The Notice of Compliance was issued on October 17, 2025 and makes Yesintek commercially available in Canada by mid-October. 

Yesintek and Yesintek IV are approved for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients aged 6-17, and for active psoriatic arthritis in adults, and moderately to severely active Crohn's disease and ulcerative colitis in adults.

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Approvals were granted based on a comprehensive review that confirmed that Yesintek is highly similar to Stelara and there were no clinically meaningful differences in efficacy, safety or immunogenicity between Yesintek and Stelara injections. Patients will have access to the therapy through My Biocon Biologics patient support program. Yesinterk is available as a subcutaneous injection (45 mg/0.5 ml, 90 mg/ml) and as an intravenous (IV) solution (130 mg/26 ml).

Shreehas Tambe, the CEO & Managing Director of Biocon Biologics, noted that this approval reinforces their mission to expand global access to high-quality biosimilars, particularly in Canada, and to buttress their North American presence first established after a successful launch in the U.S.

Additionally, Ramy Ayad, Biocon Biologics, Head of Canada, stated that Yesintek will provide Canadian patients a reliable and value-driven option and support efforts to increase utilization of biosimilars and savings in Canada.

With this most recent approval, Biocon Biologics continues to build upon its developing stature as a trusted global biosimilars company focused on affordable, innovative healthcare solutions.