Generics and the specific features of their regulation

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.

Авторы
Ushkalova E.A. 1 , Zyryanov S.K. 1 , Ushkalova A.V.2
Издательство
Ima-Press Publishing House
Номер выпуска
3
Язык
Русский
Страницы
82-87
Статус
Опубликовано
Том
8
Год
2016
Организации
  • 1 Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia, 6, Miklukho-Maklai St., Moscow, 117198, Russian Federation
  • 2 Mental Health Clinic, 120 Zhiv. St., Vil. of Len., Istr. Dis., Moscow Region, 143590, Russian Federation
Ключевые слова
Biosimilars; Generics; Non-biological complex drugs; Regulatory requirements
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