Wedoany.com Report-Nov. 29, Health Canada has granted regulatory approval to Celltrion's Eydenzelt (aflibercept), a biosimilar to Regeneron's Eylea. The product will be available in Canada in both pre-filled syringe and vial presentations and is authorised for all indications approved for the reference product Eylea.

Celltrion's Eylea biosimilar, Eydenzelt, has gained approval from Health Canada, making it the fifth Eylea biosimilar to be available within the country.

Approval was supported by comprehensive data from global Phase III clinical trials, together with analytical and non-clinical studies that confirmed comparable efficacy, safety, and quality between Eydenzelt and the originator medicine.

Jungyong Shin, Managing Director of Celltrion Healthcare Canada, welcomed the decision and highlighted its strategic importance for the company's growth in the ophthalmology sector.

Eydenzelt received earlier approvals from the European Commission in February 2025 and from the U.S. Food and Drug Administration in October 2025. In Canada, it becomes the third approved aflibercept biosimilar, following Yesafili from Biocon Biologics (approved June 2025) and Aflivu from Apotex (approved July 2025).

The entry of multiple biosimilars follows the expiry of key Eylea patents, increasing treatment options for patients with retinal conditions while enhancing affordability across healthcare systems.

Meanwhile, Regeneron continues to strengthen its franchise with Eylea HD, a higher-dose, longer-acting formulation. The product, first approved in the United States in 2023 for diabetic macular oedema, wet age-related macular degeneration, and diabetic retinopathy, received an additional FDA approval this month for macular oedema following retinal vein occlusion.

Regeneron is working to introduce a pre-filled syringe version of Eylea HD to improve administration convenience, though manufacturing observations at a third-party facility led to a rejection of that presentation by the FDA in October 2025. The company is addressing the observations to enable future approval.

Eylea HD competes in a growing ophthalmology market where Roche's Vabysmo has gained significant share since its 2022 launch. Despite strong performance from the newer entrant, industry forecasts project continued meaningful revenue contribution from both the Eylea franchise and its biosimilars through the coming years, supporting sustained patient access to advanced retinal therapies.