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Celltrion Gains EU Approval for Aflibercept Biosimilar Branded Eydenzelt
Author: Jennie Crabbe
South Korea’s Celltrion announced Feb. 18 that the European Commission had granted marketing authorization to Eydenzelt, an aflibercept (Eylea) biosimilar.
Eydenzelt (40 mg/mL solution for injection in vial and pre-filled syringe) is indicated for wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
EU regulators recently approved three other Eylea biosimilars: Ahzantive (aflibercept-mrbb), also known as Baiama, from German companies Formycon and Klinge Biopharma; Opuviz (aflibercept-yszy), from Samsung Bioepis and Biogen; and Afqlir (aflibercept-abzv), from Sandoz. The European Commission approved its first biosimilar to Eylea in September 2023: Yesafili, developed by India’s Biocon Biologics.
Eydenzelt was approved by Korean regulators in May 2024.
The company filed a biologics license application in the US in June 2023. Regeneron has filed several legal challenges to protect its Eylea patents in the US, however, and Celltrion is among the targets.
