Biocon Biologics gets Health Canada approval for its AMD biosimilar Yesafili
CHENNAI: Biocon Biologics, the biosimilars subsidiary of Biocon Ltd, said on Friday that Health Canada has granted a Notice of Compliance (NOC) for its age-related macular degeneration (AMD) drug, Yesafili. The drug is a biosimilar to aflibercept, marketed under the brand name Eylea by US biotech major Regeneron Pharmaceuticals.
This approval clears the way for the Canadian launch of Yesafili injection on July 4, 2025, making it the first biosimilar to Eylea approved by Health Canada.
A biosimilar is the biological equivalent of a generic drug in the field of biologics—highly similar to an already authorized reference product, with no clinically meaningful differences in terms of safety, purity, or potency.
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following central retinal vein occlusion (CRVO), macular edema following branch retinal vein occlusion (BRVO), and diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).
The approval of Yesafili was based on a comprehensive submission of analytical, nonclinical, and clinical data. Health Canada concluded that the biosimilar is highly similar to Eylea, with no clinically meaningful differences in terms of quality, safety, or efficacy.
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