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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Principais autores:	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
Formato:	Artigo
Idioma:	Russo
Publicado em:	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
coleção:	Регуляторные исследования и экспертиза лекарственных средств
Assuntos:	оригинальный биотехнологический лекарственный препарат биоаналоговый (биоподобный) лекарственный препарат качество исследования сопоставимости производство регистрация original biotechnological products biosimilar quality comparability studies manufacture marketing authorization
Acesso em linha:	https://www.vedomostincesmp.ru/jour/article/view/19
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