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Научно-практическая ревматология

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Биоаналоги в ревматологии

https://doi.org/10.14412/1995-4484-2016-628-640

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Аннотация

Одно из наиболее ярких достижений фармакотерапии ревматоидного артрита (РА) и других иммуновоспалительных заболеваний (ИВЗ) человека конца ХХ в. связано с разработкой принципиально новой группы лекарственных средств, которые получили название «генно-инженерные биологические препараты» (ГИБП). Однако внедрение инновационных ГИБП в клиническую практику не только позволило повысить эффективность терапии и улучшить прогноз у пациентов, страдающих наиболее тяжелыми формами ИВЗ, но и привело к кардинальному удорожанию лечения. Прогресс в разработке биоаналогов (biosimilars) ГИБП связан со многими факторами, в том числе c окончанием срока действия патентов на многие оригинальные ГИБП, такие как инфликсимаб, адалимумаб, этанерцепт, ритуксимаб. За последние 5 лет было разработано и продолжает разрабатываться большое число биоаналогов ГИБП. Европейское медицинское агентство (European Medicines Agency – EMA), Всемирная организация здравоохранения (ВОЗ) и Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (Food and Drug Administration – FDA) разработали регуляторные основы, общие требования к производству и характеристике биоаналогов. В Федеральном законе от 22 декабря 2014 г. № 429-ФЗ «О внесении изменений в Федеральный закон "Об обращении лекарственных средств"» биоаналоговый (биоподобный) лекарственный препарат (биоаналог) определяется как биологический лекарственный препарат, схожий по параметрам качества, эффективности и безопасности с референтным биологическим лекарственным препаратом в такой же лекарственной форме и имеющий идентичный способ введения. В обзоре представлены современные данные, касающиеся требований к биоаналогам ГИБП, применяемым для лечения ИВЗ, их взаимозаменяемости и перспектив применения в клинической практике. Особое внимание уделяется биоаналогу химерных моноклональных антител к фактору некроза опухоли α инфликсимаба – препарату Фламмэгиc (Flammegis; Egis Pharmaceuticals, Венгрия), который зарегистрирован в России для лечения РА, анкилозирующего спондилита и других ИВЗ, а также биоаналогу химерных моноклональных антител к В-лимфоцитам ритуксимаба – препарату Ацеллбия, III фаза клинических испытаний которого завешается. Сформулированы предварительные положения и рекомендации Общероссийской общественной организации «Ассоциация ревматологов России», касающиеся места биоаналогов в ревматологии.

Об авторе

Е. Л. Насонов
ФГБНУ «Научно-исследовательский институт ревматологии им. В.А. Насоновой» ФГБОУ ВО «Первый Московский государственный медицинский университет им. И.М. Сеченова» Минздрава России
Россия

115522 Москва, Каширское шоссе, 34А;

119991 Москва, ул. Трубецкая, 8, стр. 2 кафедра ревматологии Института профессионального образования, Москва, Россия



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Для цитирования:


Насонов Е.Л. Биоаналоги в ревматологии. Научно-практическая ревматология. 2016;54(6):628-640. https://doi.org/10.14412/1995-4484-2016-628-640

For citation:


Nasonov E.L. BIOSIMILARS IN RHEUMATOLOGY. Rheumatology Science and Practice. 2016;54(6):628-640. (In Russ.) https://doi.org/10.14412/1995-4484-2016-628-640

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ISSN 1995-4484 (Print)
ISSN 1995-4492 (Online)