phkineticaФармакокинетика и ФармакодинамикаPharmacokinetics and Pharmacodynamics2587-78362686-8830ООО «Издательство ОКИ»phkinetica-148Research ArticleАКТУАЛЬНЫЕ ОБЗОРЫCURRENT REVIEWSБиосимиляры - препараты будущегоBiosimilars - drugs of the futureЕльцоваЕ. А.EltcovaE. A.noemail@neicon.ruРаменскаяГ. В.RamenskayaG. V.noemail@neicon.ruСмолярчукЕ. А.SmolyarchukE. A.noemail@neicon.ruБушмановаА. В.BushmanovaA. V.noemail@neicon.ruГБОУ ВПО «Первый Московский Государственный Медицинский Университет им. И.М. Сеченова»РоссияFirst Moscow State Medical University named after I.M. SechenovRussian Federation201509042014011215Copyright © Ельцова Е.А., Раменская Г.В., Смолярчук Е.А., Бушманова А.В., 20142014Ельцова Е.А., Раменская Г.В., Смолярчук Е.А., Бушманова А.В.Eltcova E.A., Ramenskaya G.V., Smolyarchuk E.A., Bushmanova A.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmacokinetica.ru/jour/article/view/148

В статье изложены основные термины и определения, относящиеся к биосимилярам, дженерикам и оригинальным препаратам. Также описана краткая история возникновения и развития биотехнологической промышленности и препаратов, полученных с помощью биообъектов. Приведены основные различия между биосимилярами и дженериками, а также их отличия от инновационных лекарственных препаратов. Рассмотрен процесс биотехнологического производства и основные области применения биосимиляров. Проанализирована нормативно-правовая база Российской Федерации и Европейского Союза.

The article describes the basic terms and definitions relating to biosimilars, generics and original drugs. Also described a brief history of the origin and development of the biotechnology industry and drugs produced using biological objects. The main difference between biosimilars and generics, as well as their differences to innovative medicines. The process of biotechnological production, and main applications of biosimilars. It analyzed the legal framework of the Russian Federation and the European Union.

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The authors declare that there are no conflicts of interest present.