Celltrion is making a full-scale entry into the European ophthalmic disease market with its biosimilar of EYLEA (active ingredient aflibercept), "EYDENZELT."
Celltrion announced on the 14th that it has obtained product approval for EYDENZELT from the European Commission (EC). Both the EYDENZELT injection and the EYDENZELT prefilled syringe (PFS) formulations have been approved.
EYLEA is a treatment for ophthalmic diseases developed by Regeneron in the United States, including wet age-related macular degeneration, and it generated approximately 13 trillion won in global sales in 2023. The target diseases include neovascular (wet) age-related macular degeneration (wAMD), retinal vein occlusion macular edema, diabetic macular edema (DME), and myopic choroidal neovascularization. EYDENZELT has also received approval for these diseases.
Previously, Celltrion confirmed the equivalence of CT-P42 compared to the original drug through a global Phase 3 clinical trial conducted on 348 patients with diabetic macular edema. Based on these results, it received product approval from the Ministry of Food and Drug Safety in May of last year and is currently on sale. Following the domestic launch, the recent approval in Europe enables the company to target the global market.
A Celltrion representative said, "With this product approval for EYDENZELT, we can expand our product line in the European market and accelerate our strategy for global market penetration," adding, "We will do our best to achieve rapid product launches and enhance our market dominance."