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.
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