A Randomized, Open-Label Study Conducted to Evaluate the Bioequivalence of Pegfilgrastim-cbqv On-Body Injector Versus Prefilled Syringe in Healthy Male Participants.

ABSTRACT:

Introduction

To help prevent febrile neutropenia, pegfilgrastim-cbqv (UDENYCA^®; Coherus BioSciences), a pegfilgrastim (NEULASTA^®; Amgen) biosimilar, is administered 24-96 h after myelosuppressive chemotherapy. Delivery of pegfilgrastim-cbqv using an on-body injector (OBI) provides an alternative method of administration, affording options in drug delivery. This study aimed to establish pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence and assess the safety of pegfilgrastim-cbqv administered using an OBI compared with a prefilled syringe (PFS).

Methods

In this open-label, two-period crossover study, healthy adult male participants (N = 189) were randomly assigned 1:1 to receive pegfilgrastim-cbqv 6 mg subcutaneously using an OBI (n = 92) or a

SUBMITTER: Tang H 

PROVIDER: S-EPMC10879373 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature