Регуляторные подходы к оценке биоаналогов для лечения ревматических заболеваний
Аннотация
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.
Об авторах
Д. В. Горячев
НЦ экспертизы средств медицинского применения
Россия
Россия
М. Ю. Тельных
НЦ экспертизы средств медицинского применения
Россия
Россия
Н. Д. Бунятян
НЦ экспертизы средств медицинского применения
Россия
Россия
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Рецензия
Для цитирования:
Горячев Д.В., Тельных М.Ю., Бунятян Н.Д. Регуляторные подходы к оценке биоаналогов для лечения ревматических заболеваний. Ведомости Научного центра экспертизы средств медицинского применения. 2017;7(3):155-163.
For citation:
Goryachev D.V., Telnykh M.Yu., Bunyatyan N.D. Regulatory approaches to evaluation of biosimilars for treatment of rheumatic diseases. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2017;7(3):155-163. (In Russ.)
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