Document Detail

Similar biotherapeutic products: overview and reflections.
MedLine Citation:
PMID:  23240752     Owner:  NLM     Status:  In-Data-Review    
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.
Zayrho Desanvicente-Celis; Arley Gomez-Lopez; Juan-Manuel Anaya
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Immunotherapy     Volume:  4     ISSN:  1750-7448     ISO Abbreviation:  Immunotherapy     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101485158     Medline TA:  Immunotherapy     Country:  England    
Other Details:
Languages:  eng     Pagination:  1841-57     Citation Subset:  IM    
Center for Autoimmune Diseases Research (CREA), School of Medicine & Health Sciences, Universidad del Rosario, Carrera 24 # 63-C-69. Third Floor, Bogotá, Colombia.
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