FDA rejects Coherus' marketing application for Neulasta biosimilar; shares down 34% premarket

|By:, SA News Editor

Coherus BioSciences (NASDAQ:CHRS) has received a Complete Response Letter (CRL) from the FDA related to its Biologics License Application (BLA) seeking approval for CHS-1701, a biosimilar to Amgen's (NASDAQ:AMGN) Neulasta (pegfilgrastim).

The CRL cited the need for a reanalysis of a subset of subject samples with a revised immunogenicity assay and additional manufacturing-related process information.

The company says it will work with the agency to address the issues. Management will host a conference call this morning at 8:00 am ET to discuss the situation.

Shares are down 34% premarket on average volume.

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