First available biosimilar monoclonal antibodies

First available biosimilar monoclonal antibodies

The review deals with the issues related to the special aspects of the development of the first available similar biopharmaceuticals/biological analogues («biosimilars») based on monoclonal antibodies. In June 2013 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines A...

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Bibliographic Details
Main Authors: Zh. I. Avdeeva, A. A. Soldatov, N. A. Alpatova, V. P. Bondarev, Yu. V. Olefir, V. A. Merkulov, V. D. Mosyagin, N. V. Medunitsyn
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2018-02-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
биоподобные/биоаналоговые («biosimilars») препараты
лекарственные препараты моноклональных антител
оценка качества
доклинические исследования
клинические исследования
biosimilar products
monoclonal antibody products
quality assessment
preclinical trials
clinical trials
Online Access:https://www.biopreparations.ru/jour/article/view/67
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