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Биоаналоги: эволюция подходов к разработке, регулированию, контролю жизненного цикла и обеспечению взаимозаменяемости

https://doi.org/10.21518/1561-5936-2021-3-56-68

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Аннотация

Биоаналоги были впервые введены в правовое поле в 2004 г. в Евросоюзе и несколько позже в США. Параллельно с получением результатов оценки биоаналогичности происходила эволюция регуляторных подходов. Появилось четкое понимание необходимости оценки сопоставимости на каждом из этапов с целью выявления потенциала различий и определения их значимости для конечного клинического результата. Помимо приверженности подходу биоаналогичности, важно соблюдать общие требования, применимые к любым лекарствам, как к категории товаров, получаемых в промышленном масштабе. Накопленный опыт свидетельствует, что подтверждение биоаналогичности, опирающееся на аналитические и функциональные испытания, а также на исследования клинической фармакологии, носит универсальный характер и позволяет экстраполировать терапевтические показания. Установление взаимозаменяемости биоаналогов, действующее вещество которых по определению является версией действующего вещества соответствующего референтного биопрепарата, может вызывать дополнительные затруднения, однако унифицированный подход к установлению взаимозаменяемости биопрепаратов пока не разработан.

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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Рецензия

Для цитирования:


Ниязов Р.Р., Драницына М.А., Васильев А.Н., Гавришина Е.В. Биоаналоги: эволюция подходов к разработке, регулированию, контролю жизненного цикла и обеспечению взаимозаменяемости. Ремедиум. 2021;(3):56-68. https://doi.org/10.21518/1561-5936-2021-3-56-68

For citation:


Niyazov R.R., Dranitsyna M.A., Vasiliev A.N., Gavrishina E.V. Biosimilars: evolution of approaches to the development, regulation, life cycle control and interchangeability management. Remedium. 2021;(3):56-68. (In Russ.) https://doi.org/10.21518/1561-5936-2021-3-56-68

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