Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta


Journal

Pharmacology research & perspectives
ISSN: 2052-1707
Titre abrégé: Pharmacol Res Perspect
Pays: United States
ID NLM: 101626369

Informations de publication

Date de publication:
04 2020
Historique:
received: 16 12 2019
revised: 24 02 2020
accepted: 01 03 2020
entrez: 26 4 2020
pubmed: 26 4 2020
medline: 7 4 2021
Statut: ppublish

Résumé

MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim (Neulasta

Identifiants

pubmed: 32333641
doi: 10.1002/prp2.578
pmc: PMC7183238
doi:

Substances chimiques

Antibodies 0
Biosimilar Pharmaceuticals 0
pegfilgrastim 3A58010674
Polyethylene Glycols 3WJQ0SDW1A
Filgrastim PVI5M0M1GW

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e00578

Informations de copyright

© 2020 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.

Références

J Oncol Pharm Pract. 2016 Oct;22(5):702-16
pubmed: 26769697
Eur J Cancer. 2011 Jan;47(1):8-32
pubmed: 21095116
BMC Cancer. 2011 Sep 23;11:404
pubmed: 21943360
BioDrugs. 2009;23(3):175-86
pubmed: 19627169
Blood. 1996 Sep 15;88(6):1907-29
pubmed: 8822908
Pharmacol Res Perspect. 2020 Apr;8(2):e00578
pubmed: 32333641
Crit Rev Oncol Hematol. 2014 Jan;89(1):112-28
pubmed: 24041627
Biologicals. 2015 Sep;43(5):298-306
pubmed: 26144595
Biometrics. 1991 Dec;47(4):1399-408
pubmed: 1786325

Auteurs

Chris Wynne (C)

Christchurch Clinical Studies Trust Ltd, Christchurch, New Zealand.

Christian Schwabe (C)

Auckland Clinical Studies Ltd, Auckland, New Zealand.

Emmanuelle Vincent (E)

Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.

Armin Schueler (A)

Biostatistics, Merck Healthcare, Darmstadt, Germany.

Janka Ryding (J)

SVAR Life Science - Wieslab AB, Lund, Sweden.

Martin Ullmann (M)

Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.

Vishal Ghori (V)

Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.

Radmila Kanceva (R)

Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.

Michael Stahl (M)

Fresenius Kabi SwissBioSim GmbH, Eysins, Switzerland.

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Classifications MeSH