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Alteogen Subsidiary Submits EU Application for Aflibercept Biosimilar

Jul 1, 2024

On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept)According to the press release, Altos Biologics expects to receive approval by 2025 and intends to negotiate licence agreements with potential distributors worldwide. 
Altos Biologics completed enrolment in its Phase III trials of ALT-L9 in patients with nAMD in February 2023The trials reportedly demonstrated therapeutic equivalence between ALT-L9 and Eylea®.  
Biocon received marketing approval for its aflibercept biosimilar (Yesafili®) in the UK (November 2023) and the EU (September 2023), while Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023.