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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
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....
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256126/ https://www.ncbi.nlm.nih.gov/pubmed/32022282 http://dx.doi.org/10.1111/bcp.14226 |
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author | Bellon, Anne Wang, Jessie Skerjanec, Andrej Velinova, Maria Dickerson, Daniel Sabet, Ahad Ngo, Ly O'Reilly, Terry Tomek, Charles Schussler, Steven Schier‐Mumzhiu, Stefanie Gattu, Sreekanth Koch, Sven D. Schelcher, Celine Dobreva, Miryana Boldea, Anca Nakov, Roumen Otto, Gordon P. |
author_facet | Bellon, Anne Wang, Jessie Skerjanec, Andrej Velinova, Maria Dickerson, Daniel Sabet, Ahad Ngo, Ly O'Reilly, Terry Tomek, Charles Schussler, Steven Schier‐Mumzhiu, Stefanie Gattu, Sreekanth Koch, Sven D. Schelcher, Celine Dobreva, Miryana Boldea, Anca Nakov, Roumen Otto, Gordon P. |
author_sort | Bellon, Anne |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7256126 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-72561262020-06-01 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 Bellon, Anne Wang, Jessie Skerjanec, Andrej Velinova, Maria Dickerson, Daniel Sabet, Ahad Ngo, Ly O'Reilly, Terry Tomek, Charles Schussler, Steven Schier‐Mumzhiu, Stefanie Gattu, Sreekanth Koch, Sven D. Schelcher, Celine Dobreva, Miryana Boldea, Anca Nakov, Roumen Otto, Gordon P. Br J Clin Pharmacol Original Articles 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. John Wiley and Sons Inc. 2020-02-21 2020-06 /pmc/articles/PMC7256126/ /pubmed/32022282 http://dx.doi.org/10.1111/bcp.14226 Text en © 2020 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Bellon, Anne Wang, Jessie Skerjanec, Andrej Velinova, Maria Dickerson, Daniel Sabet, Ahad Ngo, Ly O'Reilly, Terry Tomek, Charles Schussler, Steven Schier‐Mumzhiu, Stefanie Gattu, Sreekanth Koch, Sven D. Schelcher, Celine Dobreva, Miryana Boldea, Anca Nakov, Roumen Otto, Gordon P. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7256126/ https://www.ncbi.nlm.nih.gov/pubmed/32022282 http://dx.doi.org/10.1111/bcp.14226 |
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