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.

Authors
Ushkalova E.A. 1 , Zyryanov S.K. 1 , Ushkalova A.V.2
Journal
Nevrologiya, Neiropsikhiatriya, Psikhosomatika
Publisher
Ima-Press Publishing House
Number of issue
3
Language
Russian
Pages
82-87
Status
Published
Link
External link
DOI
10.14412/2074-2711-2016-3-82-87
Volume
8
Year
2016
Organizations
  • 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
Keywords
Biosimilars; Generics; Non-biological complex drugs; Regulatory requirements
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