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...

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Bibliographic Details
Main Authors:	E. A. Ushkalova, S. K. Zyryanov, A. V. Ushkalova
Format:	Article
Language:	Russian
Published:	IMA-PRESS LLC 2016-11-01
Series:	Nevrologiâ, Nejropsihiatriâ, Psihosomatika
Subjects:	generics biosimilars non-biological complex drugs regulatory requirements
Online Access:	https://nnp.ima-press.net/nnp/article/view/653

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spelling	doaj-b5bd93afb2234538a49ab43772d932182021-07-29T08:58:37ZrusIMA-PRESS LLCNevrologiâ, Nejropsihiatriâ, Psihosomatika2074-27112310-13422016-11-0183828710.14412/2074-2711-2016-3-82-87592Generics and the specific features of their regulationE. A. Ushkalova0S. K. Zyryanov1A. V. Ushkalova2Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia, Moscow, Russia 6, Miklukho-Maklai St., Moscow 117198Department of General and Clinical Pharmacology, Peoples' Friendship University of Russia, Moscow, Russia 6, Miklukho-Maklai St., Moscow 117198Mental Health Clinic, Moscow Region, Russia 120 Zhivopisnaya St., Village of Lenino, Istrinsky District, Moscow Region 143590The 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.https://nnp.ima-press.net/nnp/article/view/653genericsbiosimilarsnon-biological complex drugsregulatory requirements
collection	DOAJ
language	Russian
format	Article
sources	DOAJ
author	E. A. Ushkalova S. K. Zyryanov A. V. Ushkalova
spellingShingle	E. A. Ushkalova S. K. Zyryanov A. V. Ushkalova Generics and the specific features of their regulation Nevrologiâ, Nejropsihiatriâ, Psihosomatika generics biosimilars non-biological complex drugs regulatory requirements
author_facet	E. A. Ushkalova S. K. Zyryanov A. V. Ushkalova
author_sort	E. A. Ushkalova
title	Generics and the specific features of their regulation
title_short	Generics and the specific features of their regulation
title_full	Generics and the specific features of their regulation
title_fullStr	Generics and the specific features of their regulation
title_full_unstemmed	Generics and the specific features of their regulation
title_sort	generics and the specific features of their regulation
publisher	IMA-PRESS LLC
series	Nevrologiâ, Nejropsihiatriâ, Psihosomatika
issn	2074-2711 2310-1342
publishDate	2016-11-01
description	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.
topic	generics biosimilars non-biological complex drugs regulatory requirements
url	https://nnp.ima-press.net/nnp/article/view/653
work_keys_str_mv	AT eaushkalova genericsandthespecificfeaturesoftheirregulation AT skzyryanov genericsandthespecificfeaturesoftheirregulation AT avushkalova genericsandthespecificfeaturesoftheirregulation
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Generics and the specific features of their regulation

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