БИОПОДОБНЫЕ ЛЕКАРСТВЕННЫЕ ПРЕПАРАТЫ, ПОЛУЧЕННЫЕ С ИСПОЛЬЗОВАНИЕМ ТЕХНОЛОГИИ РЕКОМБИНАНТНЫХ ДНК

В обзоре представлены материалы, касающиеся научных принципов, лежащих в основе разработки, доклинических и клинических исследований, регистрации и контроля безопасности биоподобных (биоаналогичных) препаратов, получаемых с использованием методов генной инженерии. Количество используемых в клинике биоподобных лекарственных препаратов, определяемых как «biosimilars», неуклонно увеличивается. Отражены особенности биотехнологических препаратов, что требует необходимости особого подхода при оценке доказательства сходства/подобия вновь разработанного препарата с оригинальным (референтным) препаратом. Для обеспечения эффективности и безопасности применения биоподобных (биоаналогичных) лекарственных препаратов порядок их регистрации определяется нормативной базой, регламентирующей требования по доказательству подобия с ранее одобренным биологическим лекарственным препаратом. Отражены данные, касающиеся различий характера и объема исследований на этапах оценки качества, доклинической и клинической разработки биоподобных и оригинальных препаратов. Отражены вопросы, связанные с экстраполяцией результатов клинических исследований, и вопросы взаимозаменяемости препаратов. Приведена современная информация о международном опыте регистрации биоподобных лекарственных препаратов, научных достижениях и регуляторных требованиях, касающихся доказательства сходства/подобия при оценке качества, эффективности и безопасности биоподобных биотехнологических лекарственных препаратов («biosimilars»).

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