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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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 |
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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
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Series: | Регуляторные исследования и экспертиза лекарственных средств |
Subjects: | |
Online Access: | https://www.vedomostincesmp.ru/jour/article/view/19 |
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