USFDA informs Biocon, Mylan of deferred action on biosimilar license plea

Biotechnology major Biocon on Friday said its arm, Biocon Biologics, and Mylan have been informed by the US health regulator of a deferred action on the biologics license application (BLA) for a biosimilar to drug Avastin, used to treat various types of cancers.

Biocon Biologics Ltd and Mylan, a subsidiary of Viatris Inc, have been informed by the US Food and Drug Administration (USFDA) of a deferred action on the BLA for MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), Biocon said in a regulatory filing.

“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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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