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: | , , , , |
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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 |