Biocon Limited has informed the Exchange regarding a press release dated Jun 27, 2025, titled "Biocon Biologics Receives Health Canada Approval for Yesafili (aflibercept); First Global Launch Scheduled for July 2025".
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Biocon's subsidiary Biocon Biologics has received Health Canada approval for Yesafili, a biosimilar to Eylea (aflibercept) used to treat serious eye conditions like wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusions. Yesafili is the first biosimilar to Eylea to be approved in Canada. The product will be launched in Canada on July 4, 2025, making it Biocon Biologics' 10th biosimilar to be commercialized worldwide and the first country globally to get this product. The approval was backed by a Phase 3 INSIGHT Study showing no clinically meaningful differences from Eylea in safety, efficacy, or quality. Biocon Biologics currently serves over 5.8 million patients across 120+ countries and already has 9 commercialized biosimilars in its portfolio.
Positive for shareholders as it strengthens Biocon Biologics' global biosimilars portfolio and gives the company a first-mover advantage as the only Eylea biosimilar in the Canadian market. Revenue contribution will depend on uptake, pricing, and market share in Canada, with no specific financial guidance provided in the release.