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Comparability of Biosimilar Filgrastim with Originator Filgrastim: Protein Characterization, Pharmacodynamics, and Pharmacokinetics

BACKGROUND: Biosimilars provide safety, purity, and potency similar to those of a reference biologic product. METHODS: An array of protein analytical techniques was used to compare the physicochemical properties of proposed biosimilar filgrastim (EP2006), US-approved originator filgrastim, and EU-ap...

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Detalhes bibliográficos
Publicado no:BioDrugs
Main Authors: Sörgel, Fritz, Schwebig, Arnd, Holzmann, Johann, Prasch, Stefan, Singh, Pritibha, Kinzig, Martina
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2015
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4412827/
https://ncbi.nlm.nih.gov/pubmed/25837839
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-015-0124-7
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