Identidad Institucional CRAI
Logo EdocUR
    • English
    • español
    • português
  •  Work Submission
  •  FAQs
  • English 
    • English
    • español
    • português
  • Login

Contacto

Twitter

Facebook

Youtube

View Item 
  •   Repositorio Institucional EdocUR - Universidad del Rosario
  • Investigación
  • Artículos
  • View Item
  •   Repositorio Institucional EdocUR - Universidad del Rosario
  • Investigación
  • Artículos
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Similar biotherapeutic products: overview and reflections.

  • Exportar citas ▼
    • Exportar a Mendeley
    • Exportar a BibTex
Thumbnail
Date
2012
Author
Desanvicente-Celis, Zayrho
Gomez-Lopez, Arley
Anaya, Juan-Manuel
Métricas

Share
Citation
URI
https://doi.org/10.2217/imt.12.128
https://repository.urosario.edu.co/handle/10336/24284

Abstract
"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."

Keyword

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 ;

Source link

https://www.scopus.com/inward/record.uri?eid=2-s2.0-84878642716&doi=10.2217%2fim...

Show full item record

Collections
  • Artículos [6079]
Política de Acceso Abierto URPortal de Revistas URRepositorio de Datos de Investigación URCiencia Abierta UR
 

 

Browse

All of DSpaceCommunities & CollectionsTitlesAuthorsTypeSubjectsAdvisorBy Issue DateThis CollectionTitlesAuthorsTypeSubjectsAdvisorBy Issue Date

My Account

LoginRegister

Statistics

View Usage Statistics
Política de Acceso Abierto URPortal de Revistas URRepositorio de Datos de Investigación URCiencia Abierta UR