FDA rejects Coherus’ reworked Neulasta biosimilar due to third-party inspections

The FDA has rejected Coherus BioSciences’ new presentation for its Udenyca (pegfilgrastim-cbqv) biosimilar due to an inspection at one of its contractors.

Coherus said the BLA for its updated biosimilar to Amgen’s Neulasta was rejected due to ongoing inspection problems at this unnamed third party.

But no issues were found…
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