THE WORLD PRACTICE IN THE ASSESSMENT OF THE INTERCHANGEABILITY OF BIOENGINEERED DRUGS

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Issue: 
9
Year: 
2015

V.Smirnov (1,2), L. Krasnykh (1), V. Merkulov (1), N. Bunyatyan (1,2), G. Ramenskaya (1,2), E. Yeltsova (1), E. Smolyarchuk (2), E. Yegorenkov (2), A. Bushmanova (2) 1 -Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, Moscow 2 -I.M. Sechenov First Moscow State Medical University

In this article, main terms and definitions related to biosimilars, generic and original drugs are given. Furthermore, history brief of biotechnical industry rise and development with drugs produced by bio objects is presented. Here, main differences between biosimilars and generic drugs are explained, as well as their difference from brand-name drug. Biotechnical process and main application area of biosimilars are reviewed. Rules and regulations in Russia and EU are analyzed.
Keywords: 
biosimilars
biotechnology
generic drugs

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