Pandemic delays FDA decision on Biocon's bevacizumab application

Center for Biosimilars

27 December 2020 - For Bengaluru, Karnataka, India–based Biocon Biologics, the pandemic has interrupted the FDA review process for its planned bevacizumab biosimilar.

Biocon has been informed by the FDA that a decision on its biologics license application for the bevacizumab biosimilar candidate MYL-14020, referencing Avastin, has been deferred while the agency awaits an opportunity to inspect the company’s manufacturing facility.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Biosimilar