The FDA has approved Celltrion’s EYDENZELT® (aflibercept-boav), a biosimilar referencing Regeneron Pharmaceuticals’ EYLEA® (aflibercept), marking a new entrant into the high-value ophthalmology biologics market.
EYDENZELT is indicated for the treatment of several retinal diseases, including neovascular (wet) age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion. The biosimilar contains the same active ingredient as EYLEA, a vascular endothelial growth factor (VEGF) inhibitor that helps slow abnormal blood vessel growth in the eye and reduce fluid leakage.
The FDA’s approval was based on a totality-of-evidence assessment, including comparative analytical, preclinical, and clinical data demonstrating that EYDENZEL is highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency. The agency also confirmed interchangeable status is not currently designated for the product.
Celltrion’s entry into the U.S. ophthalmology biosimilar field follows several high-profile approvals of anti-VEGF biosimilars this year, reflecting increased competition in a category historically dominated by Regeneron and Bayer’s Eylea franchise. Analysts expect biosimilars of aflibercept to play a key role in reducing treatment costs for retinal diseases as payers and providers seek alternatives to branded anti-VEGF therapies.
EYDENZEL joins Celltrion’s growing U.S. biosimilar portfolio, which includes treatments in oncology, gastroenterology, and immunology, further positioning the company among leading global players in the biologics and biosimilars sector.
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