Biosimilars in the practice of modern oncologist

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Abstract

Currently, genetically engineered drugs are widely used in oncological clinical practice which has significantly increased treatment cost. One of the most effective ways to decrease cost is substitution of an innovative drug after patent expiration with a reproduced compound – biosimilar.

In this article, a problem of biosimilars is actualized both worldwide and in Russia, characteristics of these products are described, and the path of the agents from the moment of reproduction through preclinical and clinical trials to introduction into real clinical practice is traced, examples of such trials are presented.

The results of clinical trials of effectiveness and safety of Pembroria® in patients with various oncological pathologies are described in detail. The first data from the multicenter prospective post-marketing trial PERFECTION are presented demonstrating similar effectiveness and tolerability results for the biosimilar in a multicohort patient category compared to pembrolizumab molecule.

Manufacturing of high-quality analogs and their introduction into clinical practice create a possibility to provide more patients in need with modern highly effective and safe drugs as well as increases effectiveness of the state healthcare system.

About the authors

I. M. Shevchuk

N.A. Lopatkin Research Institute of Urology and Interventional Radiology – branch of the National Medical Research Radiological Center, Ministry of Health of Russia;
Medical Institute of Continuing Education, Russian Biotechnological University

Author for correspondence.
Email: imshevchuk@mail.ru
ORCID iD: 0000-0002-6877-0437

Irina M. Shevchuk 

Build. 1, 51 3rd Parkovaya St., Moscow 105425, 

11 Volokolamskoe Shosse, Moscow 125080

Russian Federation

A. S. Kalpinskiy

P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia

ORCID iD: 0000-0002-2209-3020

3 2nd Botkinskiy Proezd, Moscow 125284

Russian Federation

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