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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...
Autores principales: | Sörgel, Fritz, Schwebig, Arnd, Holzmann, Johann, Prasch, Stefan, Singh, Pritibha, Kinzig, Martina |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4412827/ https://www.ncbi.nlm.nih.gov/pubmed/25837839 http://dx.doi.org/10.1007/s40259-015-0124-7 |
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