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Biosimilars: Key regulatory considerations and similarity assessment tools
A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which t...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698755/ https://www.ncbi.nlm.nih.gov/pubmed/28842986 http://dx.doi.org/10.1002/bit.26438 |
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author | Kirchhoff, Carol F. Wang, Xiao‐Zhuo Michelle Conlon, Hugh D. Anderson, Scott Ryan, Anne M. Bose, Arindam |
author_facet | Kirchhoff, Carol F. Wang, Xiao‐Zhuo Michelle Conlon, Hugh D. Anderson, Scott Ryan, Anne M. Bose, Arindam |
author_sort | Kirchhoff, Carol F. |
collection | PubMed |
description | A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences in purity, potency, and safety between the two products. The development of biosimilars is a challenging, multistep process. Typically, the assessment of similarity involves comprehensive structural and functional characterization throughout the development of the biosimilar in an iterative manner and, if required by the local regulatory authority, an in vivo nonclinical evaluation, all conducted with direct comparison to the reference product. In addition, comparative clinical pharmacology studies are conducted with the reference product. The approval of biosimilars is highly regulated although varied across the globe in terms of nomenclature and the precise criteria for demonstrating similarity. Despite varied regulatory requirements, differences between the proposed biosimilar and the reference product must be supported by strong scientific evidence that these differences are not clinically meaningful. This review discusses the challenges faced by pharmaceutical companies in the development of biosimilars. |
format | Online Article Text |
id | pubmed-5698755 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-56987552017-11-30 Biosimilars: Key regulatory considerations and similarity assessment tools Kirchhoff, Carol F. Wang, Xiao‐Zhuo Michelle Conlon, Hugh D. Anderson, Scott Ryan, Anne M. Bose, Arindam Biotechnol Bioeng Reviews A biosimilar drug is defined in the US Food and Drug Administration (FDA) guidance document as a biopharmaceutical that is highly similar to an already licensed biologic product (referred to as the reference product) notwithstanding minor differences in clinically inactive components and for which there are no clinically meaningful differences in purity, potency, and safety between the two products. The development of biosimilars is a challenging, multistep process. Typically, the assessment of similarity involves comprehensive structural and functional characterization throughout the development of the biosimilar in an iterative manner and, if required by the local regulatory authority, an in vivo nonclinical evaluation, all conducted with direct comparison to the reference product. In addition, comparative clinical pharmacology studies are conducted with the reference product. The approval of biosimilars is highly regulated although varied across the globe in terms of nomenclature and the precise criteria for demonstrating similarity. Despite varied regulatory requirements, differences between the proposed biosimilar and the reference product must be supported by strong scientific evidence that these differences are not clinically meaningful. This review discusses the challenges faced by pharmaceutical companies in the development of biosimilars. John Wiley and Sons Inc. 2017-09-19 2017-12 /pmc/articles/PMC5698755/ /pubmed/28842986 http://dx.doi.org/10.1002/bit.26438 Text en © 2017 Pfizer Inc. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc. This is an open access article under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Reviews Kirchhoff, Carol F. Wang, Xiao‐Zhuo Michelle Conlon, Hugh D. Anderson, Scott Ryan, Anne M. Bose, Arindam Biosimilars: Key regulatory considerations and similarity assessment tools |
title | Biosimilars: Key regulatory considerations and similarity assessment tools |
title_full | Biosimilars: Key regulatory considerations and similarity assessment tools |
title_fullStr | Biosimilars: Key regulatory considerations and similarity assessment tools |
title_full_unstemmed | Biosimilars: Key regulatory considerations and similarity assessment tools |
title_short | Biosimilars: Key regulatory considerations and similarity assessment tools |
title_sort | biosimilars: key regulatory considerations and similarity assessment tools |
topic | Reviews |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698755/ https://www.ncbi.nlm.nih.gov/pubmed/28842986 http://dx.doi.org/10.1002/bit.26438 |
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