Health Canada granted Notice of Compliance for Yesintek, Biocon Biologics' ustekinumab biosimilar to Stelara, on October 17, 2025, enabling commercial launch in mid-October.
The approval covers treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease and ulcerative colitis in specified patient populations.
Yesintek demonstrated high similarity to reference biologic Stelara with no clinically meaningful differences in efficacy, safety, or immunogenicity based on comprehensive data package.
The biosimilar will be available in multiple formulations including subcutaneous injections and intravenous infusion, strengthening Biocon's North American market presence.
