International nonproprietary names for biological and biotechnological drugs
Abstract
About the Authors
V. V. DudchenkoRussian Federation
P. I. Popov
Russian Federation
N. D. Bunyatyan
Russian Federation
A. N. Yavorsky
Russian Federation
V. A. Merkulov
Russian Federation
References
1. Guidelines on use of International Nonproprietary Names (INNs) for Pharmaceutical Substances. WHO/PHARM S/Nom 1570. Geneva: WHO; 1997.
2. International Nonproprietary Names: revised procedure. Procedure for the selection of recommended international nonproprietary names for pharmaceutical substances. EB115.R4. Geneva: WHO; 2005.
3. WHO/EMP/RHT/TSN/2013.1. The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances. 2013.
4. WHO International Nonproprietary Names (INN) for Biological and Biotechnological Substances. A Review. Programme on International Nonproprietary Names (INN). Quality Assurance and Safety: Medicines (QSM). Medicines Policy and Standards (PSM) Department.
5. Vasiliev AN, Gavrishina EV, Niyazov RR, Snegireva AA, Adonin VK. Introduction to the European legislation on medicines. Biological medicines. Remedium 2013; (9): 49–54 (in Russian).
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9. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations. U.S. Food and Drug Administration. Available from: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm.
10. Vasiliev AN, Gavrishina EV, Niyazov RR, Dobrovolskiy AV, Tuter EA, Bekerman AN. Biologically similar drugs in the Russian Federation and prospects of their development. Remedium 2013; (7–8): 67–70 (in Russian).
Review
For citations:
Dudchenko V.V., Popov P.I., Bunyatyan N.D., Yavorsky A.N., Merkulov V.A. International nonproprietary names for biological and biotechnological drugs. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(4):32-38. (In Russ.)