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Биоаналоги: воспроизведение клинического профиля с помощью современных биотехнологий

https://doi.org/10.21518/1561-5936-2021-2-8-24

Полный текст:

Аннотация

Биоаналог является биологическим лекарственным препаратом, который содержит версию действующего вещества ранее разрешенного оригинального биопрепарата. Подход к разработке биоаналогов кардинально отличается от разработки оригинального биопрепарата, поскольку основные усилия направлены на максимально точное воспроизведение действующего вещества оригинального биопрепарата. Концепция биоаналогичности признает невозможность полного воспроизведения оригинального биопрепарата и тем самым допускает определенные различия, если они не влияют на клинический профиль. Для установления биоаналогичности необходим обширный комплекс аналитических испытаний, и обнаруженные структурные различия далее оцениваются в функциональных испытаниях. Дальнейшие (до)клинические исследования нужны, чтобы доказать, что применение биоаналога приводит к такому же клиническому результату, как и применение оригинального биопрепарата, а не для того, чтобы заново подтвердить безопасность и эффективность.

Об авторах

Р. Р. Ниязов
Центр научного консультирования
Россия

к.м.н.

Москва



М. А. Драницына
Центр научного консультирования
Россия

Москва



А. Н. Васильев
Центр научного консультирования
Россия

д.биол.н.

Москва



Е. В. Гавришина
Центр научного консультирования
Россия

к.м.н.

Москва



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Для цитирования:


Ниязов Р.Р., Драницына М.А., Васильев А.Н., Гавришина Е.В. Биоаналоги: воспроизведение клинического профиля с помощью современных биотехнологий. Ремедиум. 2021;(2):8-24. https://doi.org/10.21518/1561-5936-2021-2-8-24

For citation:


Niyazov R.R., Dranitsyna M.A., Vasiliev A.N., Gavrishina E.V. Biosimilars: reproduction of the clinical profile using modern biotechnology. Remedium. 2021;(2):8-24. (In Russ.) https://doi.org/10.21518/1561-5936-2021-2-8-24

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