Comparison of the Pharmacokinetic and Pharmacodynamic Biosimilarity of CHS-1701 (Coherus Pegfilgrastim) With Neulasta® (Pegfilgrastim)

Phase 1 Completed 116 enrolled Coherus Oncology, Inc.

RandomizedCrossoverTriple-blind

Summary

This is a randomized, double-blind, single-dose, 2-period crossover study in healthy subjects to assess PK, PD, and safety (including immunogenicity) of a single 6 mg subcutaneous (SC) injection of CHS-1701 compared with a single 6 mg SC dose of Neulasta®.

Timeline

Start: 2015-02
Primary completion: 2015-07
Completion: 2015-07

Publications

Civoli F, Finck B, Tang H, Hodge J, O'Kelly H, Vexler V. Biosimilar Pegfilgrastim-cbqv Demonstrated Similar Immunogenicity to Pegfilgrastim in Healthy Subjects Across Three Randomized Clinical Studies. Adv Ther. 2022 Mar;39(3):1230-1246. doi: 10.1007/s12325-021-02024-x. Epub 2022 Jan 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CHS-1701	Unknown	6 mg	Subcutaneous
Subject	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous

Indications

No indication recorded.