European Commission grants marketing authorization to aflibercept biosimilar EYLUXVI (ALT-L9)

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The European Commission (EC) has granted marketing authorization for EYLUXVI (ALT-L9), an aflibercept (Eylea) biosimilar from Alteogen, co-developed by its subsidiary, Alteogen Biologics.¹

EYLUXVI is Alteogen's second approved biosimilar; the other approval is the company’s trastuzumab (Herceptin) biosimilar. Alteogen received a positive opinion for EYLUXV from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in July of this year.²

The company stated that with the newly granted marketing authorization, EYLUXVI is now approved for use across Europe for wet age-related macular degeneration (AMD), macular edema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (myopic CNV).

Soon Jae Park, PhD, CEO of Alteogen, commented on the marketing authorization in a press release¹ from the company, saying, “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,” Park continued. “We remain committed to improving patient access to effective therapies for serious ophthalmic conditions, including macular degeneration.”

The EC approval was based on the phase 3 clinical trials conducted by Alteogen Biologics in 12 countries throughout Europe, South Korea, and Japan from June 2022 to February 2024, including follow-up through 52 weeks. In the trial, 431 participants with wet AMD were randomized 1:1 to receive either EYLUXVI (n = 216) or aflibercept (n = 215). The primary efficacy endpoint of the study was the change from baseline in best corrected visual acuity (BCVA). The study's results confirmed therapeutic equivalence and showed comparable safety profiles between the two treatments.

References

1. Alteogen Receives European Commission Approval for Aflibercept Biosimilar, EYLUXVI® (ALT-L9). Published September 17, 2025. Accessed September 17, 2025. https://www.prnewswire.com/news-releases/alteogen-receives-european-commission-approval-for-aflibercept-biosimilar-eyluxvi-alt-l9-302558913.html
2. Harp MD. Alteogen receives positive CHMP opinion for aflibercept biosimilar EYLUXVI. Published July 28, 2025. Accessed Septembet 17, 2025. https://europe.ophthalmologytimes.com/view/alteogen-receives-positive-chmp-opinion-for-aflibercept-biosimilar-eyluxvi-ema-decision