EC Approves Alteogen’s EYLUXVI Aflibercept Biosimilar

The European Commission (EC) has officially granted marketing authorization for EYLUXVI (ALT-L9), a biosimilar of aflibercept (Eylea) developed by Alteogen in collaboration with its subsidiary, Alteogen Biologics. With this decision, EYLUXVI becomes Alteogen’s second approved biosimilar and is now authorized for use across Europe in treating several major retinal diseases.

Approved Indications Across Multiple Retinal Conditions

EYLUXVI is now approved in the European Union for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following branch or central retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).

The product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July 2025, paving the way for this EC decision.

Global Development and Clinical Validation

The EC approval was supported by data from a Phase 3 clinical trial conducted by Alteogen Biologics from June 2022 to February 2024 across 12 countries, including Europe, South Korea, and Japan.

In the randomized, controlled trial, 431 patients with wet AMD were assigned to receive either EYLUXVI (n = 216) or reference aflibercept (n = 215). The primary endpoint was the change in best corrected visual acuity (BCVA) from baseline.

Results confirmed therapeutic equivalence between EYLUXVI and aflibercept, with comparable safety profiles observed throughout the 52-week follow-up period.

EYLUXVI Gains Approval Following Clinical and Regulatory Milestones

EYLUXVI represents Alteogen’s first biosimilar developed entirely through independent in-house research and brought to market following global clinical development led by Alteogen Biologics.

Soon Jae Park, PhD, CEO of Alteogen, commented:

“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 research and development but also by gaining valuable experience with the European regulatory approval process. We remain committed to improving patient access to effective therapies for serious ophthalmic conditions, including macular degeneration.”