Microcap's effort to take on Eylea with Avastin biosimilar faces significant FDA roadblock
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.
“We remain confident in ONS-5010 and its potential to be the first FDA-approved ophthalmic formulation of bevacizumab that avoids the public health risk to patients of off-label treatment,” CEO Russell Trenary said in a statement.
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