On 13 September 2024, Korea Biomedical Review reported that Korea-based Alteogen has submitted a domestic marketing authorisation application for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept), for treatment of nAMD.
This follows Alteogen’s subsidiary, Altos Biologics’, MAA submission to the EMA in July 2024 for ALT-L9, with marketing approval expected in 2025. Altos Biologics completed enrolment in its phase 3 trials of ALT-L9 in patients with nAMD in February 2023. The trials reportedly demonstrated therapeutic equivalence between ALT-L9 and Eylea®.
The first aflibercept biosimilar approved in Korea was Samsung Bioepis’ Afilivu® in February 2024, which is being marketed by Samil Pharmaceutical. Celltrion’s Eydenzelt™ (CT-P42) (aflibercept) received Korean approval in May 2024.