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Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab
BACKGROUND: Regulatory approval for a biosimilar product is provided on the basis of its comparability to an originator product. A thorough physicochemical and functional comparability exercise is a key element in demonstrating biosimilarity. Here we report the characterization of a proposed biosimi...
Autores principales: | Visser, Jan, Feuerstein, Isabel, Stangler, Thomas, Schmiederer, Timo, Fritsch, Cornelius, Schiestl, Martin |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3775154/ https://www.ncbi.nlm.nih.gov/pubmed/23649935 http://dx.doi.org/10.1007/s40259-013-0036-3 |
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