The beginning of the new era of monoclonal antibodies biosimilars use in oncology:current international guidelines and the results of clinical trial of the first Russian rituximab biosimilar in patients with B-cell non-Hodgkin’s lymphoma
This article contains the detailed analysis of current approach to non-clinical and clinical development of monoclonal antibody biosimilars which is described in current guidelines of the European Medicines Agency (2012). Requirements of European regulatory authorities regarding evidence, which allo...
Main Authors: | K D Kaplanov, A Yu Zaritskey, S M Alekseev, R A Ivanov, E V Chernyaeva |
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Format: | Article |
Language: | Russian |
Published: |
IP Habib O.N.
2014-06-01
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Series: | Современная онкология |
Subjects: | |
Online Access: | https://modernonco.orscience.ru/1815-1434/article/view/26947 |
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