We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency ("EMA") for ALT-L9, what has since been named EYLUXVI. EYLUXVI is a proposed biosimilar to Regeneron's EYLEA (aflibercept). Alteogen had previously announced clinical results demonstrating similarity between EYLUXVI and EYLEA.
On July 28, 2025, Alteogen announced that the EMA's Committee for Medicinal Products for Human Use ("CHMP") adopted a positive opinion for EYLUXVI. The CHMP recommends approval for EYLUXVI to treat neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization (CNV).
EYLUXVI would be Alteogen's second commercialized biosimilar product. It previously commercialized a Herceptin biosimilar, ALT-L2.
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