USFDA defers action on BLA for Avastin biosimilar, notifies Biocon Biologics, Mylan

To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard review process
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Biocon Biologics, and Mylan, a subsidiary of Viatris, have been informed by the US FDA of deferred action on the biologics license application (BLA) for a biosimilar to drug Avastin (bevacizumab), used to treat various types of cancers.

“To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard review process. However, due to restrictions on travel related to COVID-19, the agency is unable to conduct an inspection during the current review cycle. We await the dates for the inspection,” it added.

“There are no additional observations related to the application,” Biocon Biologics spokesperson said.

AvastinbevacizumabBiocon BiologicsBiologics License ApplicationbiosimilarMylanUS FDAViatris
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