A Randomized, Double-Blind, 2-Period Parallel-Arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of CHS-1701 (Coherus Pegfilgrastim) With 2 Subcutaneous Doses 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
- 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.
- 27 Jul 2018 According to a Coherus Biosciences media release, the European Commission decision on the approval for UDENYCA is expected in October.
- 27 Jul 2018 According to a Coherus Biosciences media release, the CHMP of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of UDENYCA (formerly CHS-1701). UDENYCAs marketing authorization application to EMA was supported by the analytical similarity data as well as a 3-arm, triple-crossover pharmacokinetic (PK) and pharmacodynamics (PD) study in healthy subjects(see profile 267265) and this trial.