Here are four things to know.
- Neulasta, which earned about $4.6 billion in sales last year, is used to treat infections in cancer patients.
- The biosimilar represents one of Coherus’ lead experimental drugs, according to Reuters.
- Upon notification of the rejection, the FDA asked the drugmaker to reanalyze data and provide additional manufacturing information, according to the report.
- Coherus said it plans to work with the agency to address its concerns.
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