Biocon Biologics Ltd. (BBL), a global biosimilars company and subsidiary of Biocon Ltd., has announced that Health Canada has granted a Notice of Compliance (NOC) for Yesafili™ (aflibercept), a biosimilar to Eylea® (aflibercept). The approval, received on June 26, 2025, covers both vial and prefilled syringe presentations (2 mg/0.05 mL), and marks the first approval of an Eylea biosimilar in Canada. The company plans to launch the product in the Canadian market on July 4, 2025.
Yesafili, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of several serious eye conditions, including neovascular (wet) age-related macular degeneration (AMD), macular edema due to central and branch retinal vein occlusion (CRVO and BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).
The approval is based on a robust data package comprising analytical, nonclinical, and clinical studies that demonstrated Yesafili's high similarity to Eylea, with no clinically meaningful differences in terms of quality, safety, and efficacy.
Commenting on the milestone, Shreehas Tambe, CEO and Managing Director of Biocon Biologics Ltd., said, “The approval of YESAFILI by Health Canada—the first biosimilar to EYLEA® in Canada—is a proud moment for Biocon Biologics. We are excited that in July, Canada will be the first country where we will launch YESAFILI, making it our 10th biosimilar to be commercialized worldwide. This milestone reflects our science-driven innovation, global commercialization strength, and continued commitment to expanding access to high-quality, affordable biologics for patients across the globe.”
Ramy Ayad, Head of Canada at Biocon Biologics, added, “This is a significant achievement for Biocon Biologics in Canada. With the approval of YESAFILI, we are delivering on our promise to improve access to advanced biologic therapies. Canadian ophthalmologists and patients will soon have a high-quality, affordable biosimilar option for serious retinal diseases.”