THE ORIGINAL AND GENERIC DRUGS: CURRENT STATE OF THE PROBLEM

Article is devoted to modern problems of quality control, efficiency and safety of the generic drugs. Definitions are given to a number of terms ? reference drug, generic drugs, pharmaceutical, pharmacokinetic, therapeutic equivalence, according to the current legislation of the Russian Federation (The federal law ?About the address of medicines? of April 12, 2010 No 61-FZ with changes from 7.13.2015). Requirements to an assessment of pharmaceutical, pharmacokinetic and therapeutic equivalence of generics to reference drugs are described. Approaches of Guidance for Industry Bioequivalence Recommendations for Specific Products (USA) are given to research of therapeutic equivalence of drugs.