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

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

Outcome

Met primary endpoint

release “study of CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This study met its primary PD endpoints” coherus.com ↗

release “clinical study of CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This study met all of its co-primary endpoints” coherus.com ↗

release “results from its pharmacokinetic and pharmacodynamic (PK/PD) clinical study of CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This study met its primary PD endpoints” coherus.com ↗

release “CHS-1701-05. All co-primary endpoints for PK, Cmax and Area Under the Curve (AUC), and PD, absolute neutrophil count (ANC max and ANC AUC) were achieved.” coherus.com ↗

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.