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Generics and the specific features of their regulation

https://doi.org/10.14412/2074-2711-2016-3-82-87

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Abstract

The article discusses the factors that influence the efficacy and safety of generic drugs, including regular generics, biosimilars, and generic nonbiological complex drugs. It emphasizes the importance of adequate regulatory requirements to provide a comparable therapeutic efficacy and a comparable cost-effectiveness ratio for generics versus brand-name drugs.

About the Authors

E. A. Ushkalova
Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia, Moscow, Russia 6, Miklukho-Maklai St., Moscow 117198
Russian Federation


S. K. Zyryanov
Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia, Moscow, Russia 6, Miklukho-Maklai St., Moscow 117198
Russian Federation


A. V. Ushkalova
Mental Health Clinic, Moscow Region, Russia 120 Zhivopisnaya St., Village of Lenino, Istrinsky District, Moscow Region 143590
Russian Federation


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For citation:


Ushkalova E.A., Zyryanov S.K., Ushkalova A.V. Generics and the specific features of their regulation. Neurology, Neuropsychiatry, Psychosomatics. 2016;8(3):82-87. (In Russ.) https://doi.org/10.14412/2074-2711-2016-3-82-87

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)