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-135Research ArticleОБЗОРЫREVIEWSРегуляторные подходы к оценке биоаналогов для лечения ревматических заболеванийRegulatory approaches to evaluation of biosimilars for treatment of rheumatic diseasesГорячевД. В.GoryachevD. V.noemail@neicon.ruТельныхМ. Ю.TelnykhM. Yu.noemail@neicon.ruБунятянН. Д.BunyatyanN. D.noemail@neicon.ruНЦ экспертизы средств медицинского примененияРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation20171302201873155163Copyright © Горячев Д.В., Тельных М.Ю., Бунятян Н.Д., 20182018Горячев Д.В., Тельных М.Ю., Бунятян Н.Д.Goryachev D.V., Telnykh M.Y., Bunyatyan N.D.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/135

Рассмотрены вопросы планирования программ разработки биоаналогичных препаратов, которые применяют для терапии пациентов с ревматическими заболеваниями. Проанализированы основные определения биоаналогичных препаратов, применяемые в Российской Федерации и за рубежом, а также регуляторные подходы к признанию биоаналогичности. Описан дизайн подтверждающих клинических исследований. Отмечено, что обоснование границ эквивалентности должно строиться как на клинических, так и на статистических предпосылках. Обоснована необходимость постоянного совершенствования требований и подходов к оценке достаточности программ изучения этих препаратов.

The article discusses the design of development programmes for biosimilars used to treat patients with rheumatic diseases. It analyses the most popular definitions of biosimilars that are used in Russia and abroad, as well as regulatory approaches to establishing biosimilarity. The authors describe the design of confirmatory clinical trials and draw attention to the fact that equivalence margins need to be justified on both clinical and statistical grounds. The article substantiates the need to continuously improve the requirements for and approaches to the assessment of the programmes’ applicability to biosimilars evaluation.

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