Microcap's effort to take on Eylea with Avastin biosimilar faces significant FDA roadblock

Microcap's effort to take on Eylea with Avastin biosimilar faces significant FDA roadblock

Source: 
Endpoints
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A small biotech trying to develop an Avastin biosimilar to treat wet AMD has run into a setback.

Outlook Therapeutics withdrew its BLA for bevacizumab, the active compound in Roche/Genentech’s Avastin cancer therapy, after the FDA requested additional information to complete the application, the biotech said Tuesday. Outlook plans to resubmit its BLA by September of this year.