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: 27 Jul 2018

At a glance

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

    • 27 Jul 2018 According to Coherus BioSciences media release, UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date expected on or before November 3, 2018.
    • 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.
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