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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Shranjeno v:
Bibliografske podrobnosti
izdano v:BioDrugs
Main Authors: 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
Format: Artigo
Jezik:Inglês
Izdano: Springer International Publishing 2015
Teme:
Original Research Article
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC4562010/
https://ncbi.nlm.nih.gov/pubmed/26334631
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-015-0136-3
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