Alteogen’s aflibercept biosimilar EYZANFY (ALT-L9) wins MFDS approval in Korea, expanding access to retinal therapies and lowering treatment costs.
Written By: Mahathi Palivela, PharmD
Reviewed By: Pharmacally Editorial Team
Alteogen said South Korea’s Ministry of Food and Drug Safety (MFDS) has granted approval to EYZANFY™ (ALT-L9), its aflibercept biosimilar for retinal diseases, on May 15, 2026. The authorization follows earlier European approval under the brand name Eyluxvi® and was supported by a global Phase 3 trial (NCT04058535) involving 431 patients with wet age-related macular degeneration (wet AMD), demonstrating therapeutic equivalence and comparable safety to Eylea®.
EYZANFY is approved in South Korea for all indications of the reference product, including wet AMD, diabetic macular edema (DME), macular edema following retinal vein occlusion, and myopic choroidal neovascularization associated with pathologic myopia. Alteogen plans to commercialize the product domestically through.
The authorization strengthens Alteogen’s position in the growing biosimilars market and increases competition in South Korea’s aflibercept segment, where biosimilars from, and are already available. While Eylea is reimbursed at approximately 493,543 won per vial, competing biosimilars are priced between 198,000 and 330,000 won, positioning EYZANFY as a potentially more accessible treatment option for patients and healthcare systems.
Beyond South Korea, the milestone expands Alteogen’s regulatory track record and could support future international submissions and strategic partnerships. The launch further highlights the growing role of biosimilars in improving access to retinal therapies while supporting more sustainable healthcare delivery.
Reference
Alteogen Receives MFDS Approval for Aflibercept Biosimilar, EYZANFY (ALT-L9) – 뉴스 – 알테오젠 ALTEOGEN
About the Writer
Mahathi Palivela (LinkedIn) is pursuing PharmD and has a strong interest in Clinical Pharmacy and Patient safety. She is passionate about handling and analyzing patient data, and translating clinical insights into clear, meaningful summaries. She aims to apply this interest in Medical Writing and Pharmacovigilance, focusing on improving patient outcomes through careful data interpretation and communication.
