FDA Accepts Amgen’s BLA for ABP 938, Biosimilar to Regeneron’s Eylea® (Aflibercept)

Amgen announced in its Q3 2023 results that the FDA has accepted its Biologics License Application (BLA) for ABP 938, its biosimilar to Regeneron’s Eylea® (aflibercept).  Amgen did not include the FDA target action date in its announcement.

On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.