On 17 July 2024, Boan Biotech announced that China’s Centre for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted its BLA for BA9101, biosimilar to Regeneron’s Eylea® (aflibercept). The BA9101 application is for all Eylea® indications, namely nAMD and diabetic macular oedema.
In the US, aflibercept biosimilars have been approved for Samsung Bioepis’ Opuviz™ (May 2024), Biocon’s Yesafili™ (May 2024) and Formycon/Klinge’s FYB203/Ahzantive® (June 2024). These and other aflibercept biosimilars are the subject of BPCIA litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Biocon/Mylan.
Biocon received marketing approval for Yesafili™ in the UK (November 2023) and the EU (September 2023), while Formycon’s MAA for FYB203 was accepted by EMA in December 2023. On 1 July 2024, South Korea’s Alteogen announced that its subsidiary Altos Biologics submitted an MAA to the EMA for its aflibercept biosimilar, ALT-L9.
In Korea, Samsung Bioepis’ Afilivu® and Celltrion’s EydenzeltTM (CT-P42) received approval as biosimilars to Eylea® in February 2024 and May 2024, respectively.