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Биоаналоги: разработка и изучение с помощью современных биотехнологий

https://doi.org/10.14341/DM12576

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Аннотация

Биоаналоги — это биологические лекарственные препараты, имеющие сопоставимый с оригинальными биопрепаратами клинический профиль (профиль эффективности и безопасности), но разрабатываемые по сокращенной программе. Для разработки биоаналогов используется специальный подход на основе обратной инженерии, предполагающий глубокий анализ оригинального биопрепарата и последующее создание его версии, максимально близкой к нему по структурным и функциональным свойствам. Такой подход включает оценку и сравнение биоаналога и оригинального биопрепарата с точки зрения структуры молекулы и профиля примесей и их биологической активности в условиях in vitro, а также фармакокинетических, фармакодинамических и иммунологических свойств на людях. При необходимости могут быть проведены исследования на животных и клинические исследования III фазы, если остается неопределенность с точки зрения биоаналогичности, которую не удалось устранить с помощью предыдущих исследований и испытаний. Любые потенциально неизбежные остающиеся различия должны быть незначимы для профиля безопасности и эффективности. Современные методы биотехнологии и аналитики при соблюдении соответствующих научно-регуляторных требований позволяют создавать биоаналоги, клинический профиль которых сопоставим с таковым оригинального биопрепарата. Накопленный международный опыт свидетельствует о том, что не должно возникать явных проблем, обусловленных несопоставимостью между биоаналогом и оригинальным биопрепаратом, если выполнены применимые научные стандарты и регуляторные предписания.

Об авторах

Р. Р. Ниязов
Центр научного консультирования
Россия

Ниязов Равиль Рашидович, к.м.н.; eLibrary SPIN: 8413-0907

123557, Москва, Пресненский вал, 14, с. 1



М. А. Драницына
Центр научного консультирования
Россия

Драницына Маргарита Александровна; eLibrary SPIN: 8338-3685

Москва



А. Н. Васильев
Центр научного консультирования
Россия

Васильев Андрей Никифорович, д.б.н.; eLibrary SPIN: 5046-7810

Москва



Е. В. Гавришина
Центр научного консультирования
Россия

Гавришина Елена Валериевна, к.м.н.; eLibrary SPIN: 4445-4185

Москва



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Для цитирования:


Ниязов Р.Р., Драницына М.А., Васильев А.Н., Гавришина Е.В. Биоаналоги: разработка и изучение с помощью современных биотехнологий. Сахарный диабет. 2020;23(6):548-560. https://doi.org/10.14341/DM12576

For citation:


Niyazov R.R., Dranitsyna M.A., Vasiliev A.N., Gavrishina E.V. Biosimilars: development and investigation using achievements in modern biotechnology. Diabetes mellitus. 2020;23(6):548-560. (In Russ.) https://doi.org/10.14341/DM12576

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