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 with this new Udenyca biosimilar’s clinical trials, drug efficacy, safety, labeling or manufacturing, the company said in a press release. Coherus is working closely with the FDA and third party to bring the drug to approval as quickly as possible.
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