Biocon said its arm, Biocon Biologics, and Mylan have been informed by the FDA of a deferred action on the biologics license application for a biosimilar to drug Avastin, MYL-1402O, as reported livemint.com.
"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," Biocon said.
"There are no additional observations related to the application," a Biocon Biologics spokesperson added.
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