Biocon Biologics Ltd has secured Health Canada approval for its ustekinumab biosimilars, Yesintek™ and Yesintek™ I.V., paving the way for these therapies to become commercially available across Canada. The Notice of Compliance, granted on October 17, validates Yesintek’s comparability with Janssen’s Stelara® and recognizes no clinically meaningful differences in efficacy, safety, or immunogenicity, based on extensive clinical data including the pivotal STELLAR-2 Phase III study.
Yesintek and Yesintek I.V. are indicated for the treatment of moderate to severe plaque psoriasis in adults and children aged 6–17, as well as active psoriatic arthritis, Crohn’s disease, and ulcerative colitis—conditions that affect thousands of Canadians and often require long-term biological therapy. These biosimilars will be distributed through My Biocon Biologics™, the company’s patient support program aimed at helping patients transition to biosimilar therapies with ease.
Available as both subcutaneous injections (45 mg/0.5 mL, 90 mg/mL) and intravenous solutions (130 mg/26 mL), Yesintek provides a broader, cost-effective option for both public and private healthcare markets.
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