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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Autores Principales: Desanvicente-Celis, Zayrho, Gomez-Lopez, Arley, Anaya, Juan-Manuel
Formato: Artículo (Article)
Lenguaje:Inglés (English)
Publicado: 2012
Materias:
Acceso en línea:https://repository.urosario.edu.co/handle/10336/24284
https://doi.org/10.2217/imt.12.128
id ir-10336-24284
recordtype dspace
spelling 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