Yesintek is ustekinumab injection and Yesintek I.V. is ustekinumab for injection, solution for intravenous infusion. These drugs are biosimilars of Stelara (ustekinumab injection) and Stelara I.V. (ustekinumab for injection, solution for intravenous infusion).
The 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.
The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October.
YESINTEK and YESINTEK I.V. are 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.
Shreehas Tambe, CEO & managing director, Biocon Biologics, said: 'Health Canada’s approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars.
Building on our successful U.S. launch, this approval strengthens our presence in North America and enhances our immunology portfolio with a more affordable treatment option for Canadian patients living with chronic autoimmune conditions.'
Biocon is a global biopharma company dedicated to improving affordable access to therapies for chronic conditions such as diabetes, cancer, and autoimmune diseases.
In its latest financial results, Biocon reported a 95.2% decline in consolidated net profit to Rs 31.40 crore despite a 15.8% jump in net sales to Rs 3,910.10 crore in Q1 FY26 compared to Q1 FY25.
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