Biocon Biologics Receives Health Canada Approval for Yesintek™ and Yesintek™ I.V., a Biosimilar to Stelara®

Biocon Biologics Ltd, a fully integrated global biosimilars company and subsidiary of Biocon Ltd, has announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek™ (ustekinumab injection) and Yesintek™ 1|.V. (ustekinumab for injection, solution for intravenous infusion), a biosimilar to Stelara® (ustekinumab injection) and Stelara® I.V. (ustekinumab for injection, solution for intravenous infusion). The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October. 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. Health Canada approval was based on a comprehensive data package, confirming that Yesintek™ is highly similar to Stelara® with no clinically meaningful differences in efficacy, safety and immunogenicity.