Meta-analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim.

ABSTRACT: A meta-analysis using data from 3 phase 1 studies evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of Sandoz biosimilar versus US- and EU-reference pegfilgrastim. The studies included a single-dose, double-blind, 3-arm, parallel-group study (study 1); a single-dose, double-blind, 2-way crossover study (study 2); and a single-dose, double-blind, 3-way, 6-sequence crossover study (study 3). Healthy male and female subjects were randomized to receive the proposed biosimilar (all studies), US-reference biologic (studies 1 and 3), or EU-reference biologic (studies 1, 2, and 3). For PK parameters (area under the serum concentration-time curve from time of dosing and extrapolated to infinity, area under the serum concentration-time curve from the time of dosing to the last measurable

SUBMITTER: Gattu S 

PROVIDER: S-EPMC9290022 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature