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An Integrated Approach for a Structural and Functional Evaluation of Biosimilars: Implications for Erythropoietin

BACKGROUND: Authorization to market a biosimilar product by the appropriate institutions is expected based on biosimilarity with its originator product. The analogy between the originator and its biosimilar(s) is assessed through safety, purity, and potency analyses. OBJECTIVE: In this study, we pro...

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Detalles Bibliográficos
Autores principales: Gianoncelli, Alessandra, Bonini, Sara A., Bertuzzi, Michela, Guarienti, Michela, Vezzoli, Sara, Kumar, Rajesh, Delbarba, Andrea, Mastinu, Andrea, Sigala, Sandra, Spano, Pierfranco, Pani, Luca, Pecorelli, Sergio, Memo, Maurizio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4562010/
https://www.ncbi.nlm.nih.gov/pubmed/26334631
http://dx.doi.org/10.1007/s40259-015-0136-3