Biocon Biologics, a subsidiary of Biocon and Mylan (a subsidiary
of Viatris Inc.) have been informed by the U.S. Food and Drug Administration (FDA) of a deferred action on the Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab).
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.
There are no additional observations related to the application.
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