Biosimilars: development and investigation using achievements in modern biotechnology

Biosimilars are biological drug products that have an equivalent clinical profile with innovator biotherapeutics but are developed under a reduced program. To this end, specific comparability approaches are followed based on reverse engineering that involves a thorough analysis of the innovator biot...

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Autores principales:	R. R. Niyazov, M. A. Dranitsyna, A. N. Vasiliev, E. V. Gavrishina
Formato:	article
Lenguaje:	EN RU
Publicado:	Endocrinology Research Centre 2021
Materias:	biosimilar follow-on biologic biotechnology variability quality immunogenicity comparability Nutritional diseases. Deficiency diseases RC620-627
Acceso en línea:	https://doaj.org/article/3890df950eda4cfaab3a564c6fd838b2
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spelling	oai:doaj.org-article:3890df950eda4cfaab3a564c6fd838b22021-11-14T09:00:23ZBiosimilars: development and investigation using achievements in modern biotechnology2072-03512072-037810.14341/DM12576https://doaj.org/article/3890df950eda4cfaab3a564c6fd838b22021-02-01T00:00:00Zhttps://www.dia-endojournals.ru/jour/article/view/12576https://doaj.org/toc/2072-0351https://doaj.org/toc/2072-0378Biosimilars are biological drug products that have an equivalent clinical profile with innovator biotherapeutics but are developed under a reduced program. To this end, specific comparability approaches are followed based on reverse engineering that involves a thorough analysis of the innovator biotherapeutics and the development of the version of the latter, which should be as much as possible similar with respect to structural and functional characteristics with the innovator. This approach includes the evaluation and comparison between the biosimilar and innovator biologic with respect to the molecular structure and impurity profile and of biological activity in in vitro settings as well as pharmacokinetic, pharmacodynamic, and immunogenicity characteristics on human subjects. Where considered necessary, animal studies or phase 3 clinical studies might be performed when residual uncertainties remain in terms of biosimilarity, that could not have been resolved in the previous tests and trials. Any potentially inevitable differences should be insignificant for safety and efficacy. The state-of-the-art methods of biotechnology and analytics, when applied in line with the appropriate scientific and regulatory requirements, can allow developing similar biologics where no difference in the clinical profile exists with the respective innovator product. Available experience demonstrates the lack of major problems due to the incomparability between the biosimilar and corresponding reference biologics when applicable scientific standards and regulatory recommendations are met.R. R. NiyazovM. A. DranitsynaA. N. VasilievE. V. GavrishinaEndocrinology Research Centrearticlebiosimilarfollow-on biologicbiotechnologyvariabilityqualityimmunogenicitycomparabilityNutritional diseases. Deficiency diseasesRC620-627ENRUСахарный диабет, Vol 23, Iss 6, Pp 548-560 (2021)
institution	DOAJ
collection	DOAJ
language	EN RU
topic	biosimilar follow-on biologic biotechnology variability quality immunogenicity comparability Nutritional diseases. Deficiency diseases RC620-627
spellingShingle	biosimilar follow-on biologic biotechnology variability quality immunogenicity comparability Nutritional diseases. Deficiency diseases RC620-627 R. R. Niyazov M. A. Dranitsyna A. N. Vasiliev E. V. Gavrishina Biosimilars: development and investigation using achievements in modern biotechnology
description	Biosimilars are biological drug products that have an equivalent clinical profile with innovator biotherapeutics but are developed under a reduced program. To this end, specific comparability approaches are followed based on reverse engineering that involves a thorough analysis of the innovator biotherapeutics and the development of the version of the latter, which should be as much as possible similar with respect to structural and functional characteristics with the innovator. This approach includes the evaluation and comparison between the biosimilar and innovator biologic with respect to the molecular structure and impurity profile and of biological activity in in vitro settings as well as pharmacokinetic, pharmacodynamic, and immunogenicity characteristics on human subjects. Where considered necessary, animal studies or phase 3 clinical studies might be performed when residual uncertainties remain in terms of biosimilarity, that could not have been resolved in the previous tests and trials. Any potentially inevitable differences should be insignificant for safety and efficacy. The state-of-the-art methods of biotechnology and analytics, when applied in line with the appropriate scientific and regulatory requirements, can allow developing similar biologics where no difference in the clinical profile exists with the respective innovator product. Available experience demonstrates the lack of major problems due to the incomparability between the biosimilar and corresponding reference biologics when applicable scientific standards and regulatory recommendations are met.
format	article
author	R. R. Niyazov M. A. Dranitsyna A. N. Vasiliev E. V. Gavrishina
author_facet	R. R. Niyazov M. A. Dranitsyna A. N. Vasiliev E. V. Gavrishina
author_sort	R. R. Niyazov
title	Biosimilars: development and investigation using achievements in modern biotechnology
title_short	Biosimilars: development and investigation using achievements in modern biotechnology
title_full	Biosimilars: development and investigation using achievements in modern biotechnology
title_fullStr	Biosimilars: development and investigation using achievements in modern biotechnology
title_full_unstemmed	Biosimilars: development and investigation using achievements in modern biotechnology
title_sort	biosimilars: development and investigation using achievements in modern biotechnology
publisher	Endocrinology Research Centre
publishDate	2021
url	https://doaj.org/article/3890df950eda4cfaab3a564c6fd838b2
work_keys_str_mv	AT rrniyazov biosimilarsdevelopmentandinvestigationusingachievementsinmodernbiotechnology AT madranitsyna biosimilarsdevelopmentandinvestigationusingachievementsinmodernbiotechnology AT anvasiliev biosimilarsdevelopmentandinvestigationusingachievementsinmodernbiotechnology AT evgavrishina biosimilarsdevelopmentandinvestigationusingachievementsinmodernbiotechnology
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Biosimilars: development and investigation using achievements in modern biotechnology

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