International nonproprietary names for biological and biotechnological drugs

The article presents generalized information about the program of the World Health Organization (WHO) related to International Nonproprietary Names (INN) of biological and biotechnological drugs. It reflects general principles for selecting INN for biological and biotechnological preparations, immun...

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Bibliographic Details
Main Authors: V. V. Dudchenko, P. I. Popov, N. D. Bunyatyan, A. N. Yavorsky, V. A. Merkulov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
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Online Access:https://www.vedomostincesmp.ru/jour/article/view/62
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Summary:The article presents generalized information about the program of the World Health Organization (WHO) related to International Nonproprietary Names (INN) of biological and biotechnological drugs. It reflects general principles for selecting INN for biological and biotechnological preparations, immunoglobulins (sera), preparations for gene therapy, glycosylated proteins and peptides, non-glycosylated proteins peptides and proteins, hybrid proteins, blood preparations, monoclonal antibodies, skin substitutes, transgenic products, vaccines, biosimilars. The conclusion was made about the need for an early solution to the global problem of assigning INN to biological and biotechnological drugs, while the number of authorized products remains relatively small.
ISSN:3034-3062
3034-3453