Biocon subsidiary gets Health Canada nod for YESAFILI
Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has received a Notice of Compliance from Health Canada for YESAFILI™ (aflibercept), marking a significant milestone in the company's global biosimilars journey. The regulatory approval, granted on June 26, 2025, makes YESAFILI the first biosimilar to EYLEA® (aflibercept) to be approved in Canada. The product will be available in both vial and prefilled syringe forms (2 mg/0.05 mL), with its commercial launch set for July 4, 2025.
YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor designed to treat several serious eye conditions. These include neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and visual impairment due to macular edema caused by retinal vein occlusion (CRVO and BRVO), as well as myopic choroidal neovascularization (myopic CNV).
The approval is backed by a robust data package encompassing analytical, nonclinical, and clinical studies. Health Canada concluded that YESAFILI matches EYLEA in quality, safety, and effectiveness, with no clinically meaningful differences.
This milestone not only reinforces Biocon Biologics' capabilities in developing high-quality biosimilars but also enhances patient access to affordable treatment options in Canada.
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Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at BusinessUpturn.com
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