FDA informs Biocon, Mylan of deferred action on Avastin biosimilar license application - (livemint.com via NewsPoints Desk)

  • 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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