БИОСИМИЛЯРЫ: ПРОБЛЕМЫ ЗАМЕЩЕНИЯ И СОВРЕМЕННЫЕ ТРЕБОВАНИЯ К ВОСПРОИЗВЕДЕННЫМ ПРЕПАРАТАМ ИНСУЛИНА


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Аннотация

Проведенные к настоящему времени исследования убедительно доказали существенные различия в эффективности и безопасности терапии между оригинальными и воспроизведенными биотехнологическими препаратами (биосимилярами). Тем не менее, несмотря на множество свидетельств терапевтической неэквивалентности, существует опасность “автоматического " замещения оригинальных препаратов на биосимиляры в связи с более низкой стоимостью. Сложившаяся ситуация требует пересмотра законодательной базы, регулирующей обращение биосимиляров в нашей стране.

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Об авторах

М. В Шестакова

Эндокринологический научный центр, Москва; Эндокринологический диспансер Департамента здравоохранения города Москвы

д.м.н., профессор, член-корр. РАМН

М. Б Анциферов

Эндокринологический научный центр, Москва; Эндокринологический диспансер Департамента здравоохранения города Москвы

д.м.н., профессор

О. К Викулова

Эндокринологический научный центр, Москва; Эндокринологический диспансер Департамента здравоохранения города Москвы

к.м.н.

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