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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
Author(s) -
Bellon Anne,
Wang Jessie,
Skerjanec Andrej,
Velinova Maria,
Dickerson Daniel,
Sabet Ahad,
Ngo Ly,
O'Reilly Terry,
Tomek Charles,
Schussler Steven,
SchierMumzhiu Stefanie,
Gattu Sreekanth,
Koch Sven D.,
Schelcher Celine,
Dobreva Miryana,
Boldea Anca,
Nakov Roumen,
Otto Gordon P.
Publication year - 2020
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14226
Subject(s) - pegfilgrastim , biosimilar , medicine , tolerability , pharmacodynamics , pharmacokinetics , neutropenia , pharmacology , filgrastim , clinical endpoint , clinical trial , adverse effect , chemotherapy
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.