vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)vedomostiregmed-19Research ArticleЭКСПЕРТИЗА ЛЕКАРСТВЕННЫХ СРЕДСТВEXPERT EVALUATION OF MEDICINESПодходы к оценке биоаналогичности (биоподобия) биотехнологических лекарственных препаратов: вопросы качестваThe approaches to the assessment of biosimilarity of biotechnological preparations: quality issuesМироновА. Н.MironovA. N.noemail@neicon.ruМеркуловВ. А.MerkulovV. A.noemail@neicon.ruЛутцеваА. И.LutsevaA. I.noemail@neicon.ruВагановаО. А.VaganovaO. A.Vaganova@expmed.ruБендрышевА. А.BendryshevA. A.noemail@neicon.ruЕфремоваТ. А.EfremovaT. A.noemail@neicon.ruКириченкоЕ. В.KirichenkoE. V.noemail@neicon.ruШвецС. Б.ShvetsS. V.noemail@neicon.ruИванайненЕ. Б.IvanainenE. V.noemail@neicon.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияFederal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian FederationRussian Federation20151302201801410Copyright © Миронов А.Н., Меркулов В.А., Лутцева А.И., Ваганова О.А., Бендрышев А.А., Ефремова Т.А., Кириченко Е.В., Швец С.Б., Иванайнен Е.Б., 20182018Миронов А.Н., Меркулов В.А., Лутцева А.И., Ваганова О.А., Бендрышев А.А., Ефремова Т.А., Кириченко Е.В., Швец С.Б., Иванайнен Е.Б.Mironov A.N., Merkulov V.A., Lutseva A.I., Vaganova O.A., Bendryshev A.A., Efremova T.A., Kirichenko E.V., Shvets S.V., Ivanainen E.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.vedomostincesmp.ru/jour/article/view/19

В связи с окончанием срока действия патентов на большую часть востребованных биотехнологических лекарственных препаратов актуальной тенденцией становится увеличение количества заявок на регистрацию биоаналоговых (биоподобных) лекарственных препаратов (биоаналогов). В Российской Федерации процесс вывода на рынок биоаналоговых лекарственных препаратов только начинается. Следует ожидать, что в ближайшие годы общемировая тенденция вывода на рынок биоаналоговых копий ранее зарегистрированных препаратов станет и российской действительностью. В этой связи представляется актуальной разработка отечественных требований, предъявляемых к лекарственным препаратам, представляемым при регистрации в качестве биоаналоговых. В настоящей статье авторами предложены к обсуждению основные подходы по выбору критериев для подтверждения биоаналогичности лекарственных препаратов в части вопросов оценки их качества и определения объема исследований, необходимого для доказательства подобия и сопоставимости физико-химических и биологических свойств биоаналогичного лекарственного препарата с оригинальным.

Due to expiration of patents for most highly demanded biotechnological preparations there is a tendency for the increase in the number of applications for marketing authorisation of biosimilar preparations (biosimilars). In the Russian Federation, the process of bringing biosimilars to the market has just started. It should be expected that in the upcoming years the global tendency for brining biosimilars of previously authorized preparations will become real in Russia. In this regard there is a need for developing national requirements for drugs submitted for marketing authorization as biosimilars. In the present article the authors propose for consideration main approaches for selecting criteria for confirmation of biosimilarity in terms of their quality assessment and determining the amount of studies required to confirm the similarity and comparability of physical, chemical and biological properties of biosimilars in comparison with the originator.

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