Trial Profile
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
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 24 Jan 2022
Price :
$35
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At a glance
- Drugs Pegfilgrastim (Primary)
- Indications Neutropenia
- Focus Pharmacodynamics; Registrational
- Sponsors Coherus Biosciences
- 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.
- 25 Sep 2018 According to a Coherus Biosciences media release, the European Commission (EC) has granted marketing authorization to UDENYCA.