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USFDA informs Biocon Biologics, Mylan about biosimilar Avastin deferred action
New Delhi: 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...
New Delhi: 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.
Read also: Biocon chief Kiran Mazumdar Shaw, others lead Lancet panel for universal health coverage in India
"There are no additional observations related to the application," Biocon Biologics spokesperson said.
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Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751