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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...

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Detalles Bibliográficos
Autores principales: Visser, Jan, Feuerstein, Isabel, Stangler, Thomas, Schmiederer, Timo, Fritsch, Cornelius, Schiestl, Martin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2013
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