A Large Multicentre, Randomized, Double-blind, Cross-over Study in Healthy Volunteers to Compare Pharmacokinetics, Pharmacodynamics and Safety of a Pegfilgrastim Biosimilar with Its US- and EU-reference Biologics

Overview

Journal Br J Clin Pharmacol

Specialty Pharmacology

Date 2020 Feb 6

PMID 32022282

Citations 8

Authors

Anne Bellon

Jessie Wang

Andrej Skerjanec

Maria Velinova

Daniel Dickerson

Ahad Sabet

Ly Ngo

Terry OReilly

Charles Tomek

Steven Schussler

Stefanie Schier-Mumzhiu

Sreekanth Gattu

Sven D Koch

Celine Schelcher

Miryana Dobreva

Anca Boldea

Roumen Nakov

Gordon P Otto

Affiliations

Soon will be listed here.

Abstract

Aims: Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financial burden of this complication of chemotherapy. The aim of this study was to demonstrate biosimilarity between Sandoz biosimilar pegfilgrastim and its US- and EU-approved reference biologics.

Methods: Phase I, randomized, double-blind, single-dose, 3-period, 6-sequence cross-over, multicentre study to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of Sandoz biosimilar pegfilgrastim with US- and EU-references in healthy adults.

Results: Pharmacokinetic and pharmacodynamic similarity was demonstrated between the 3 biologics, as the 90% confidence interval for all primary pharmacokinetic and pharmacodynamic endpoint comparisons were contained within the predefined similarity margins of 0.80-1.25. Safety, immunogenicity and tolerability were also similar.

Conclusions: Sandoz biosimilar pegfilgrastim demonstrated pharmacokinetic and pharmacodynamic similarity to both US- and EU-reference biologics. No meaningful differences in safety, local tolerability and immunogenicity were identified.

Citing Articles

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Supportive therapies in the prevention of chemotherapy-induced febrile neutropenia and appropriate use of granulocyte colony-stimulating factors: a Delphi consensus statement.

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