mrjСовременная ревматологияModern Rheumatology Journal1996-70122310-158XIMA-PRESS, LLC10.14412/1996-7012-2020-2-104-109mrj-1027Research ArticleКЛИНИЧЕСКИЕ НАБЛЮДЕНИЯCLINICAL OBSERVATIONSВзаимозаменяемость оригинальных ингибиторов фактора некроза опухоли α и биосимиляров в ревматологии: опыт замены оригинального инфликсимаба на Фламмэгис при анкилозирующем спондилитеThe interchangeability of original tumor necrosis factor- α inhibitors and biosimilars in rheumatology: experience in replacing original infliximab with Flammagis for ankylosing spondylitisМуравьевЮ. В.MuravyevYu. V.

Юрий Владимирович Муравьев

115522, Москва, Каширское шоссе, 34А

Yuri Vladimirovich Muravyev

34A, Kashirskoe Shosse, Moscow 115522

murawyu@mail.ruЛебедеваВ. В.LebedevaV. V.

115522, Москва, Каширское шоссе, 34А

34A, Kashirskoe Shosse, Moscow 115522

СтарковаА. С.StarkovaA. S.

115522, Москва, Каширское шоссе, 34А

34A, Kashirskoe Shosse, Moscow 115522

РумянцеваД. Г.RumyantsevaD. G.

115522, Москва, Каширское шоссе, 34А

34A, Kashirskoe Shosse, Moscow 115522

УрумоваМ. М.UrumovaM. M.

115522, Москва, Каширское шоссе, 34А

34A, Kashirskoe Shosse, Moscow 115522

ЭрдесШ.ErdesSh.

115522, Москва, Каширское шоссе, 34А

34A, Kashirskoe Shosse, Moscow 115522

ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой»РоссияV.A. Nasonova Research Institute of RheumatologyRussian Federation202030052020142104109Copyright © Муравьев Ю.В., Лебедева В.В., Старкова А.С., Румянцева Д.Г., Урумова М.М., Эрдес Ш., 20202020Муравьев Ю.В., Лебедева В.В., Старкова А.С., Румянцева Д.Г., Урумова М.М., Эрдес Ш.Muravyev Y.V., Lebedeva V.V., Starkova A.S., Rumyantseva D.G., Urumova M.M., Erdes S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://mrj.ima-press.net/mrj/article/view/1027

Обсуждаются перспективы назначения биосимиляров ингибиторов фактора некроза опухоли α (ФНОα) при воспалительных заболеваниях суставов, их взаимозаменяемость с оригинальными препаратами. Представлены клинические наблюдения замены оригинального инфликсимаба на биосимиляр Фламмэгис при анкилозирующем спондилите. Авторы подчеркивают, что сложно прогнозировать взаимозаменяемость оригинальных ингибиторов ФНОα и биосимиляров в ревматологии, и это подтверждают приведенные клинические наблюдения. Они указывают также, что для оптимального использования биоаналогов необходимо постоянное сотрудничество ревматологов, фармакологов и регуляторных органов, направленное на защиту прав пациента с целью обеспечения безопасного, эффективного и качественного лечения. Сделан вывод о целесообразности проведения дальнейших исследований с целью развития специальной системы фармаконадзора в этой сфере.

The paper discusses prospects for prescribing tumor necrosis factor-α (TNF-α) inhibitor biosimilars, their interchangeability with original drugs for inflammatory joint diseases. It describes clinical cases when original infliximab is replaced with its biosimilar Flammagis for ankylosing spondylitis. The authors emphasize that it is difficult to predict the interchangeability of original TNF-α inhibitors and biosimilars in rheumatology, and this is confirmed by the above clinical cases. They also indicate that the optimal use of biosimilars requires a constant cooperation of rheumatologists, pharmacologists, and regulatory authorities, which is aimed at protecting the rights of a patient in order to ensure safe, effective and high-quality care. It is concluded that it is advisable to conduct further investigations to develop a special pharmacovigilance system in this area.

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