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Journal 'Cytokines & inflammation', 2016, No. 3

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Number 3'2016

The experience of biosimilar monoclonal antibody drug registration. Communication 2. Preclinical study

Zh.I. Avdeeva, A.A. Soldatov, N.A. Alpatova, Yu.V. Olefir, V.A. Merkulov, V.P. Bondarev, V.D. Mosyagin

The review provides information on the experience of the first biosimilar drugs ("biosimilars") based on monoclonal antibodies registration. In June 2013, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for Medicines (EMA) recommended licensing Remsima and Inflectra as biosimilars containing infliximab. Infliximab is a chimeric monoclonal antibody that is capable of binding the soluble and transmembrane forms of tumor necrosis factor alpha with a high degree of affinity. The drug based on such antibodies was first licensed in the EU in August 1999 under the name Remicade. These preparations are similar to the original Remicade preparation. Information on the results obtained during comparative studies of pharmacological properties, pharmacokinetic parameters, as well as the results of toxicological studies are presented. The analysis of data on the evaluation of physico-chemical characteristics, biological activity and preclinical studies of drugs, suggesting a high degree of similarity between the developed and original (referent) preparations are presented. The stage of preclinical comparative research precedes the subsequent comparative clinical studies. (Cytokines and Inflammation. 2016. Vol. 15. 34. P. 221229.).

Keywords: monoclonal antibodies, biosimilars, biosimilar biopreparations, preclinical researches, pharmacological properties, pharmacokinetic studies, toxicological studies.

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