Coherus Hoping For Expedited FDA Review Of Pegfilgrastim On-Body

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Coherus BioSciences offered clarity and insight into its three marketed biosimilar products, as the firm continues to await USFDA approval for its pegfilgrastim biosimilar using an on-body injector device.

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“Given there is not any new information to review,” Coherus BioSciences continues to anticipate approval from the “resource-constrained” US Food and Drug Administration for the company’s version of Amgen’s Neulasta (pegfilgrastim) Onpro on-body injector device using Coherus’ Udenyca (pegfilgrastim-cbqv) biosimilar “this year or in the early part of 2024.”

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