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Biocon Biologics Receives Health Canada Approval for Yesintek™ and Yesintek™ I.V. (ustekinumab), a Biosimilar to Stelara®
Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek™ (ustekinumab injection) and Yesintek™ I.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,
About this update from Biocon Limited
[{"type":"text","content":"TORONTO and BENGALURU, India, Oct. 23, 2025 /PRNewswire/ -- Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd. (BSE: 532523, NSE: BIOCON), today announced that Health Canada has granted a Notice of Compliance (NOC) for Yesintek™ (ustekinumab injection) and Yesintek™ I.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.","length":642,"tagName":"p"},{"type":"image","alt":"Biocon Biologics (PRNewsfoto/Biocon Biologics)","displaySize":"","headline":null,"caption":"Biocon Biologics (PRNewsfoto/Biocon Biologics)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":250,"url":"https://media.zenfs.com/en/cnwgroup.com/f52c945188fde03caec2c4e41e57e558"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/gWyWcCz7B.uyQ2.LsVkGvw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ0MTtjZj13ZWJw/https://media.zenfs.com/en/cnwgroup.com/f52c945188fde03caec2c4e41e57e558","width":400,"height":250}},"href":"https://mma.prnewswire.com/media/2775049/biocon_biologics_logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":370,"tagName":"p"},{"type":"text","content":"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. YESINTEK will be available through the My Biocon Biologics™ patient support program, which provides assistance to individuals prescribed with the therapy. YESINTEK is available as a subcutaneous injection, 45 mg/0.5ml (prefilled syringe and vial) and 90 mg/ml (prefilled syringe) and YESINTEK I.V. as an intravenous solution, 130 mg/26mL (5mg/mL).","length":554,"t...