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

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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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Jan 2022

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics; Registrational
  • Sponsors Coherus Biosciences

Most Recent Events

  • 16 Jan 2022 Results of a pooled analysis (NCT02418104, NCT02650973 and NCT02385851) assessing the similar immunogenicity of pegfilgrastim-cbqv and pegfilgrastim published in the Advances in Therapy
  • 02 Nov 2018 According to a Coherus Biosciences media release, the U.S. Food and Drug Administration (FDA) has approved UDENYCA (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar.
  • 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.

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