A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta in Healthy Subjects

Trial Profile

A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Oct 2016

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Coherus Biosciences
  • Most Recent Events

    • 06 Oct 2016 According to a Coherus BioSciences media release, based on the similarity data from this trial biologics license application (BLA) has been accepted by U.S.FDA.
    • 09 Aug 2016 According to a Coherus BioSciences media release, based on the similarity data from this trial biologics license application (BLA) has been submitted to U.S.FDA.
    • 01 Oct 2015 Primary endpoint has been met (Biosimilarity as measured by absolute neutrophil count) according to results published in a Coherus BioSciences media release.
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