Health Canada approves Biocon's Yesafili, biosimilar to Eylea

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

Yesafili a vascular endothelial growth factor (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 both central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), and Myopic choroidal neovascularization (myopic CNV).

The company noted that the Canadian approval was based on a comprehensive package of analytical, nonclinical, and clinical data, confirming that Yesafili is highly similar with no clinically meaningful differences to Eylea in terms of quality, safety, and efficacy.

Shreehas Tambe, CEO & managing director of Biocon Biologics commented on the approval in a press release from the company saying, “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.”

A Canadian launch of Yesafili is scheduled for July 4, 2025. Yesafili is the first biosimilar to Eylea to be approved by Health Canada.

Reference:

1. Biocon Biologics Receives Health Canada Approval for Yesafili™ (aflibercept); First Global Launch Scheduled for July 2025. Published June 27, 2025. Accessed June 30, 2025. https://www.globenewswire.com/news-release/2025/06/27/3106351/0/en/Biocon-Biologics-Receives-Health-Canada-Approval-for-Yesafili-aflibercept-First-Global-Launch-Scheduled-for-July-2025.html