FDA Defers Decision on Bevacizumab Biosimilar

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The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab).  In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more time to inspect the manufacturing facility.  Such an inspection, which is a required step of the standard review process, could not be completed during the current review cycle due to restrictions on travel related to COVID-19.  The FDA had initially aimed for a December 27, 2020 user fee goal date, but has not yet provided dates for the inspection.

Earlier this year, the FDA accepted Mylan’s aBLA for bevacizumab, adding Mylan to a list of biosimilar developers, including Amgen, Pfizer, Samsung Bioepis, and Centus (a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics), to report the filing of an aBLA for a bevacizumab biosimilar.  Mylan and Biocon’s bevacizumab biosimilar will be used to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and persistent, recurrent or metastatic cervical cancer.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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