South Korean biopharmaceutical company Alteogen Inc. (KOSDAQ:196170) announced on Wednesday that the European Commission has granted marketing authorisation for EYLUXVI (ALT-L9), an Eylea (aflibercept) biosimilar co-developed with its subsidiary Alteogen Biologics.

The approval follows a positive opinion from the Committee for Medicinal Products for Human Use in July.

Eylea is a treatment for ophthalmic diseases, including wet age-related macular degeneration (wAMD) and diabetic macular oedema (DME). EYLUXVI is now authorised across Europe for multiple indications, including wAMD, macular oedema linked to retinal vein occlusion, DME, and myopic choroidal neovascularisation.

This marks the company's second biosimilar approval, after its Herceptin biosimilar was launched in China through partner Qilu Pharmaceutical. Unlike its previous product, EYLUXVI is the first biosimilar developed through Alteogen's own in-house research.

The European Commission's decision was supported by Phase 3 clinical trials conducted in 12 countries, including Europe, South Korea, and Japan. The study, which enrolled 431 wAMD patients, demonstrated therapeutic equivalence and a comparable safety profile to Eylea.