Synopsis : Biocon Biologics has received Health Canada approval for Yesafili, its biosimilar to Regeneron’s Eylea, marking the first Eylea biosimilar approved in Canada. The launch, slated for July 4, 2025, strengthens Biocon’s global biosimilar footprint while enhancing affordable access for patients.
Biocon Biologics, the biosimilars arm of Biocon Ltd, has announced that Health Canada has granted a Notice of Compliance (NOC) for Yesafili, its biosimilar to aflibercept, the active component in Regeneron Pharmaceuticals’ Eylea. This approval, a significant milestone for Biocon Biologics, clears the path for the Canadian launch of Yesafili on July 4, 2025, making it the first Eylea biosimilar approved by Health Canada.
Biosimilars are biologic medicines highly similar to already approved reference biologics, with no clinically meaningful differences in safety, purity, or potency, and they play a critical role in improving affordability and access to advanced therapies. Aflibercept, marketed as Eylea, is a VEGF inhibitor used for treating neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema, and other serious retinal conditions.
Health Canada’s approval was based on a robust dossier of analytical, nonclinical, and clinical data, including results from the Phase 3 INSIGHT study, which found no clinically meaningful differences between Yesafili and Eylea in terms of pharmacokinetics, efficacy, safety, or immunogenicity in patients with diabetic macular edema.
Shreehas Tambe, CEO and Managing Director of Biocon Biologics, expressed pride in the milestone, highlighting that Canada will be the first country to launch Yesafili, making it the company’s 10th biosimilar to be commercialised globally. He emphasised that this approval underscores Biocon’s science-driven innovation and commitment to making biologics affordable for patients worldwide.
Ramy Ayad, Head of Canada at Biocon Biologics, noted that Canadian ophthalmologists and patients will soon have access to a high-quality, cost-effective biosimilar, supporting the management of serious retinal conditions while reducing the financial burden on patients and the healthcare system.
This approval also strengthens Biocon Biologics’ global position in the biosimilar market, reflecting the growing confidence of regulatory agencies worldwide in the company’s capabilities to deliver high-quality biologics, and aligns with its mission to democratise access to advanced therapies across geographies.
Disclaimer : This article is for informational purposes only and does not constitute medical or investment advice. Please consult a qualified healthcare professional for medical guidance and a financial advisor for investment decisions.
