A Randomized, Double-Blind, Crossover Study to Compare the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta in Healthy Subjects
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History