The approaches to the assessment of biosimilarity of biotechnological preparations: quality issues

The approaches to the assessment of biosimilarity of biotechnological preparations: quality issues

Due to expiration of patents for most highly demanded biotechnological preparations there is a tendency for the increase in the number of applications for marketing authorisation of biosimilar preparations (biosimilars). In the Russian Federation, the process of bringing biosimilars to the market ha...

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Bibliographic Details
Main Authors: A. N. Mironov, V. A. Merkulov, A. I. Lutseva, O. A. Vaganova, A. A. Bendryshev, T. A. Efremova, E. V. Kirichenko, S. V. Shvets, E. V. Ivanainen
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
оригинальный биотехнологический лекарственный препарат
биоаналоговый (биоподобный) лекарственный препарат
качество
исследования сопоставимости
производство
регистрация
original biotechnological products
biosimilar
quality
comparability studies
manufacture
marketing authorization
Online Access:https://www.vedomostincesmp.ru/jour/article/view/19

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