On 15 May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety (MFDS) has granted marketing authorisation for Eyzanfy™/ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg, for all approved reference indications. The approval comes 20 months after Alteogen submitted its Korean marketing authorisation application in September 2024.
ALT-L9 is the first biosimilar developed by Alteogen. It was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.
The first aflibercept biosimilar was approved in Korea in February 2024 – Samsung Bioepis’ Afilivu®, marketed by Samil Pharmaceutical. Celltrion’s Eydenzelt™ (CT-P42) received Korean approval in May 2024 followed by Sam Chun Dang’s SCD411 (aflibercept) in September 2025.