Similar biotherapeutic products: overview and reflections.
Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects in...
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Acceso en línea: | https://repository.urosario.edu.co/handle/10336/24284 https://doi.org/10.2217/imt.12.128 |
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ir-10336-242842022-05-02T12:37:13Z Similar biotherapeutic products: overview and reflections. Desanvicente-Celis, Zayrho Gomez-Lopez, Arley Anaya, Juan-Manuel Biosimilar agent Animal Autoimmune disease Biological therapy Biotechnology Drug approval Drug design Human Methodology Molecularly targeted therapy Neoplasm Review Animals Autoimmune diseases Biological therapy Biosimilar pharmaceuticals Biotechnology Drug approval Drug design Humans Molecular targeted therapy Neoplasms Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities. 2012 2020-05-26T00:11:09Z info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 1750743X 17507448 https://repository.urosario.edu.co/handle/10336/24284 https://doi.org/10.2217/imt.12.128 eng info:eu-repo/semantics/openAccess application/pdf instname:Universidad del Rosario |
institution |
EdocUR - Universidad del Rosario |
collection |
DSpace |
language |
Inglés (English) |
topic |
Biosimilar agent Animal Autoimmune disease Biological therapy Biotechnology Drug approval Drug design Human Methodology Molecularly targeted therapy Neoplasm Review Animals Autoimmune diseases Biological therapy Biosimilar pharmaceuticals Biotechnology Drug approval Drug design Humans Molecular targeted therapy Neoplasms |
spellingShingle |
Biosimilar agent Animal Autoimmune disease Biological therapy Biotechnology Drug approval Drug design Human Methodology Molecularly targeted therapy Neoplasm Review Animals Autoimmune diseases Biological therapy Biosimilar pharmaceuticals Biotechnology Drug approval Drug design Humans Molecular targeted therapy Neoplasms Desanvicente-Celis, Zayrho Gomez-Lopez, Arley Anaya, Juan-Manuel Similar biotherapeutic products: overview and reflections. |
description |
Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities. |
format |
Artículo (Article) |
author |
Desanvicente-Celis, Zayrho Gomez-Lopez, Arley Anaya, Juan-Manuel |
author_facet |
Desanvicente-Celis, Zayrho Gomez-Lopez, Arley Anaya, Juan-Manuel |
author_sort |
Desanvicente-Celis, Zayrho |
title |
Similar biotherapeutic products: overview and reflections. |
title_short |
Similar biotherapeutic products: overview and reflections. |
title_full |
Similar biotherapeutic products: overview and reflections. |
title_fullStr |
Similar biotherapeutic products: overview and reflections. |
title_full_unstemmed |
Similar biotherapeutic products: overview and reflections. |
title_sort |
similar biotherapeutic products: overview and reflections. |
publishDate |
2012 |
url |
https://repository.urosario.edu.co/handle/10336/24284 https://doi.org/10.2217/imt.12.128 |
_version_ |
1740172563916521472 |
score |
12,131701 |