FDA Accepts Formycon FYB203 BLA, Biosimilar To Regeneron’s Eylea® (aflibercept), For Review

Formycon and Klinge Biopharma announced that the FDA has accepted for review the BLA for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).  The FDA has assigned a target action date of June 2024.

Formycon submitted the BLA for FYB203 in June 2023.  FYB203 is being developed by Formycon and will be commercialised by Klinge Biopharma.