Datapoint: FDA Snubs Biocon’s Avastin Biosimilar

February 22

The FDA last week rejected Biocon’s Bevacizumab, a biosimilar to Roche’s blockbuster oncology drug Avastin, according to the Center for Biosimilars. Biocon gave few details on the rejection, but it likely stems from issues following an Aug. 22 manufacturing inspection. Avastin was first approved in 2004 for the treatment of colorectal cancer, an indication for which it currently holds covered or better status for 43% of insured lives under the pharmacy benefit, and 86% under the medical benefit.

SOURCE: MMIT Analytics, as of 2/15/23