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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 3. linical studies

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

In the review the information on experience of registration of the first biosimilar medical products (biosimilars) on a basis monoclonal antibodies infliximab (the antibodies specific to the tumour factor necrosis alpha) is presented. Medical products biosimilars on a basis infliximab - Remsima and Inflectra are recommended for licensing by Committee of the European Medical Agency (CHMP) in June, 2013. The specified medicinal products are similar to original preparation Remicade. In the given message data on a clinical stage on the proof of similarity of the developed preparations to an original (reference) medicinal product are furnished. Results of comparative pharmacokinetic parameters are presented; data according to safety and efficiency of medicinal products; the analysis of an immunogenicity estimation, the characteristic of revealed antibodies and their influences on pharmacokinetics, a profile of safety of medicinal products is resulted; the analysis of possibility of extrapolation of the clinical researche results on other application indications, confirmed for an original medicinal product; data on the plan of management of risks and recommendations at the subsequent monitoring of safety and efficiency of clinical application of the developed medicinal products. (Cytokines and Inflammation. 2016. Vol. 15. 34. P. 230243.)

Keywords: monoclonal antibodies, biosimilars, biosimilar preparations, clinical researches, pharmacokinetics, efficiency, safety, adverse reactions.

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