Formycon Files Aflibercept With US FDA

Formycon has submitted its FYB203 proposed biosimilar rival to Eylea (aflibercept) to the US Food and Drug Administration, marking the second public confirmation of a US biosimilar aflibercept filing after Viatris and Biocon announced their own submission in late 2021. (Also see "Viatris Believes Eylea Biosimilar Candidate Is First To Reach US FDA’s Desk" - Generics Bulletin, 10 November, 2021.)

The biologics license application for FYB203 “has been submitted to the FDA in line with the initial schedule,” Formycon said....