nnpNeurology, Neuropsychiatry, PsychosomaticsНеврология, нейропсихиатрия, психосоматика2074-27112310-1342"IMA-Press", LLC10.14412/2074-2711-2016-3-82-87nnp-653Research ArticleREVIEWSОБЗОРЫGenerics and the specific features of their regulationВоспроизведенные лекарственные средства и особенности их регулированияУшкаловаЕ. А.UshkalovaE. A.eushk@yandex.ruЗыряновС. К.ZyryanovS. K.УшкаловаА. В.UshkalovaA. V.Кафедра общей и клинической фармакологии ФГБОУ ВО «Российский университет дружбы народов», Москва, Россия 117198, Москва, ул. Миклухо-Маклая, 6РоссияDepartment of General and Clinical Pharmacology, Peoples' Friendship University of Russia, Moscow, Russia 6, Miklukho-Maklai St., Moscow 117198Russian FederationКлиника «Душевное здоровье», Московская область, Россия 143590, Московская область, Истринский район, деревня Ленино, ул. Живописная, 120РоссияMental Health Clinic, Moscow Region, Russia 120 Zhivopisnaya St., Village of Lenino, Istrinsky District, Moscow Region 143590Russian Federation201601112016838287Copyright © Ushkalova E.A., Zyryanov S.K., Ushkalova A.V., 20162016Ушкалова Е.А., Зырянов С.К., Ушкалова А.В.Ushkalova E.A., Zyryanov S.K., Ushkalova A.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://nnp.ima-press.net/nnp/article/view/653

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.

В статье обсуждаются факторы, влияющие на эффективность и безопасность воспроизведенных препаратов, включая обычные генерики, биоаналоги и воспроизведенные копии небиологических лекарственных средств сложного химического строения. Подчеркивается значение адекватных регуляторных требований для обеспечения сравнимой терапевтической эффективности и сопоставимого соотношения «затраты/эффективность» для воспроизведенных препаратов по сравнению с оригинальными.

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The authors declare that there are no conflicts of interest present.