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# FDA Approves Celltrion’s Eylea Biosimilar
- URL: https://www.fdaweb.com/fda-approves-celltrions-eylea-biosimilar/
- Published: 2025-10-10T12:00:00.000Z
- Updated: 2026-09-14T15:23:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160020

FDA has approved Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayer’s blockbuster Eylea (aflibercept) for treating several major retinal diseases, including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

FDA’s decision was based on analytical, nonclinical, and clinical data showing no clinically meaningful differences between Eydenzelt and Eylea, according to Celltrion. In a 52-week Phase 3 trial involving 348 patients with diabetic macular edema, Eydenzelt met predefined equivalence criteria for improvements in best corrected visual acuity at Week 8, the study’s primary endpoint, it says. Safety, pharmacokinetics, and immunogenicity results were also comparable to Eylea.

Aflibercept is described as a VEGF inhibitor that blocks vascular endothelial growth factor-A and placental growth factor, slowing abnormal blood vessel growth and fluid leakage in the eye.