Alteogen has announced that the European Commission (EC) has granted marketing authorisation for EYLUXVI (code name: ALT-L9), an Eylea biosimilar co-developed by its subsidiary, Alteogen Biologics.

EYLUXVI is Alteogen's second approved biosimilar, following the approval of the Herceptin biosimilar, further expanding Alteogen's biosimilar portfolio. EYLUXVI received final marketing authorisation approximately two months after obtaining a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July.

Eylea (Aflibercept) is a widely used blockbuster drug for ophthalmic diseases such as wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Oedema (DME).

With the newly-granted marketing authorisation, EYLUXVI is now approved for use across Europe, including wAMD, macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME and myopic Choroidal NeoVascularisation (myopic CNV).

Soon Jae Park, PhD, Chief Executive Officer, Alteogen, said, "EYLUXVI is the first biosimilar product developed by Alteogen through independent in-house research, followed by global clinical development in collaboration with our subsidiary Alteogen Biologics, and has ultimately secured regulatory approval. Alteogen has expanded its capabilities not only through R&D, but also by gaining valuable experience with the European regulatory approval process. We remain committed to improve patient access to effective therapies for serious ophthalmic conditions, including macular degeneration."

The EC approval was based on the phase-III clinical trials conducted by Alteogen Biologics in 12 countries, including Europe, South Korea and Japan from June 2022 to February 2024. The comparative clinical evaluation involving 431 wAMD patients demonstrated that EYLUXVI's efficacy and safety are equivalent to Eylea. The study's results confirmed therapeutic equivalence and showed comparable safety profiles between the two treatments.