Coherus BioSciences will have to wait a little longer to compete against Amgen’s Neulasta (pegfilgrastim) Onpro on-body injector device after the company received a complete response letter denying US approval for its proposed rival version using Coherus’ Udenyca (pegfilgrastim-cbqv) biosimilar.
The CRL almost certainly means that the company will not meet its forecasted timeline for the proposed on-body device. Earlier this month Coherus had explained that its application was “proceeding apace
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