Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants.

ABSTRACT:

Introduction

Pegfilgrastim-cbqv (UDENYCA^®; Coherus BioSciences, Redwood City, CA, USA) is a pegfilgrastim (Neulasta^®; Amgen, Thousand Oaks, CA, USA) biosimilar approved for administration by prefilled syringe (PFS). The recently approved pegfilgrastim-cbqv prefilled autoinjector (AI) was developed as another method of self-administration and to aid in-office use, providing flexibility in drug delivery. The objectives of the study were to assess the pharmacokinetics (PK) and pharmacodynamics (PD) to determine bioequivalence of the prefilled AI and the PFS for administration of pegfilgrastim-cbqv and to assess the safety profile of the prefilled AI.

Methods

During this open-label, two-period crossover study, healthy adult males (N = 155) were randomly ass

SUBMITTER: Tang H 

PROVIDER: S-EPMC10567933 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature