European Commission grants marketing authorisation to aflibercept biosimilar EYLUXVI (ALT-L9)
Alteogen received a positive CHMP opinion for EYLUXVI in July 2025
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The European Commission (EC) has granted marketing authorisation 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 authorisation, EYLUXVI is now approved for use across Europe for wet age-related macular degeneration (AMD), macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular oedema (DMO) and myopic choroidal neovascularisation (myopic CNV).
Soon Jae Park, PhD, CEO of Alteogen, commented on the marketing authorisation 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 randomised 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
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
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
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