Alteogen wins European approval for Eylea biosimilar Eyluxvi

17 September 2025

South Korean biotech Alteogen (KOSDAQ:196170) has secured European Commission clearance for Eyluxvi (ALT-L9), its biosimilar of Regeneron (Nasdaq: REGN) and Bayer’s (BAYN: DE) blockbuster eye drug Eylea (aflibercept). The decision comes two months after the product gained a positive recommendation from the EMA’s scientific committee.

Eyluxvi is indicated in Europe for wet age-related macular degeneration, macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. This marks Alteogen’s second approved biosimilar, following its version of Roche’s (ROG: SIX) Herceptin (trastuzumab), and the first it has advanced through full in-house research and global development.

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