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.
“The approval of YESAFILI by Health Canada—the first biosimilar to EYLEA in Canada—is a proud moment for Biocon Biologics," said Shreehas Tambe, CEO and Managing Director of Biocon Biologics.
“Canada will be the first country where we launch YESAFILI, making it our 10th biosimilar to be commercialized globally. This milestone reflects our science-led innovation, global reach, and commitment to affordable biologics,” he added.
Supporting the regulatory approval, the Phase 3 INSIGHT study compared Yesafili with Eylea in patients with diabetic macular edema. According to the company, the trial found no clinically meaningful differences in pharmacokinetics, safety, efficacy, or immunogenicity between the two drugs.
Ramy Ayad, Head of Canada at Biocon Biologics, said; “Canadian ophthalmologists and patients will soon have access to a high-quality, affordable biosimilar for serious retinal conditions.”