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Home » Coherus Slapped With CRL for Neulasta Biosimilar BLA Due to Third-Party Filler
Coherus Slapped With CRL for Neulasta Biosimilar BLA Due to Third-Party Filler
The FDA issued a complete response letter (CRL) to Coherus Biosciences on its BLA for a biosimilar of Neulasta (pegfilgrastim) solely due to an ongoing review of inspection findings at a third-party filler, the company said.