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In the review article modern approaches to testing and registration of generic drugs are discussed. The article presents the history of the formation of the methodology for testing generic drugs and the current legislation of the Russian Federation. The stages of confirmation of equivalence of original and generic drugs are described pharmaceutical equivalence, bioequivalence and therapeutic equivalence. The methods of assessing bioequivalence - as the main research in the registration of generic drugs - are discussed in detail. Using the example of the ori