On September 13, 2024, Alteogen announced that it has applied for marketing authorization in Korea for ALT-L9, an aflibercept biosimilar of EYLEA®. According to Alteogen, a 12-country Phase 3 study showed that ALT-L9 met its primary endpoint and demonstrated therapeutic equivalence to EYLEA®.
On July 1, 2024, Alteogen’s subsidiary, Altos Biologics, Inc., had submitted its Marketing Authorization Application to the European Medicines Agency (EMA) for ALT-L9. Altos Biologics stated that it expects to receive approval from the EMA by 2025.
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