Blog Big Molecule Watch January 13, 2021

FDA Defers Decision on Bevacizumab Biosimilar

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.

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