FDA rejects biosimilar of Amgen cancer drug: 4 things to know

The Food and Drug Administration denied Coherus BioSciences' biosimilar version of Amgen's successful cancer drug Neulasta.


Here are four things to know.

  1. Neulasta, which earned about $4.6 billion in sales last year, is used to treat infections in cancer patients.

  1. The biosimilar represents one of Coherus' lead experimental drugs, according to Reuters.

  1. Upon notification of the rejection, the FDA asked the drugmaker to reanalyze data and provide additional manufacturing information, according to the report.

  1. Coherus said it plans to work with the agency to address its concerns.

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