The Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion for Eydenzelt, a biosimilar to Eylea, according to a press release from Celltrion.
Eydenzelt (aflibercept 40 mg/mL) is recommended to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and myopic choroidal neovascularization. A phase 3 randomized, double-masked, parallel-group, multicenter study found that Eydenzelt demonstrated therapeutic equivalence to Eylea (aflibercept, Regeneron) through predefined equivalence