Blog Big Molecule Watch May 15, 2018

FDA accepts Coherus’s resubmitted pegfilgrastim biosimilar application

As we reported earlier this month, Coherus BioSciences recently resubmitted its application for CHS-1701, a proposed biosimilar to Neulasta® (pegfilgrastim), in response to a Complete Response Letter that it received from the FDA last June. Yesterday, Coherus announced that the FDA has accepted its pegfilgrastim resubmission and that the FDA considered the resubmission to be a complete response to its June 9, 2017 action letter. The FDA provided a biosimilar user fee action date of November 3, 2018, which is consistent with Coherus’ stated expectations last week.

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