Health Canada Approves Biocon’s Yesafili

Biocon Biologics has received a notice of compliance (NOC) from Health Canada for Yesafili (aflibercept 2 mg), a biosimilar to Eylea, available in both vial and prefilled syringe presentations at 2 mg/0.05 mL.

Indications for Yesafili in Retinal Diseases

Yesafili is a VEGF inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), visual impairment due to macular edema secondary to central retinal vein occlusion and branch retinal vein occlusion, and myopic choroidal neovascularization.

Approval Based on Robust Analytical and Clinical Data

Biocon Biologics noted that Health Canada’s approval of Yesafili was supported by a comprehensive set of analytical, nonclinical, and clinical data, demonstrating that Yesafili is highly similar to Eylea with no clinically meaningful differences in quality, safety, or efficacy.

First Biosimilar to Eylea Approved in Canada

“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,” said Shreehas Tambe, CEO and Managing Director of Biocon Biologics, in a company press release.

Launch Set for July 2025

Biocon Biologics plans to launch Yesafili in Canada on July 4, 2025. This milestone makes Yesafili the first biosimilar to Eylea approved by Health Canada, expanding treatment options for patients with retinal vascular diseases.