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Biocon Biologics Statement on the Status of Bevacizumab FDA Action Date in Dec 2020

  • Posted by: BIOCON

NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, Dec 25, 2020 –

“This is to inform you that Biocon Biologics Limited, (a subsidiary of Biocon Limited) 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. We await the dates for the inspection.

There are no additional observations related to the application.” Company Spokesperson, Biocon Biologics

Author: BIOCON
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