Document Detail

Biosimilar monoclonal antibodies: a science-based regulatory challenge.
MedLine Citation:
PMID:  23286777     Owner:  NLM     Status:  Publisher    
Monoclonal antibodies (MAs) are complex biotherapeutics as their molecular mechanism of action depends on multiple domains. Consequently regulatory approval of biosimilars of MAs is subjected to specific, science-based guidelines. An extensive comparative in vitro characterization to evaluate the biosimilarity of the various functional domains is required. The exquisite species specificity of MAs precludes reliable in vivo non-clinical evaluations and means that adequately designed clinical studies are extremely critical to confirm the biosimilarity. To date no biosimilar MAs have been approved. Taking into account the expected high development costs for biosimilar MAs, their use may well be superseded by alternative antibody formats and next-generation MAs.
Paul J Declerck
Related Documents :
8108867 - Porcine platelet antigens recognized by human xenoreactive natural antibodies.
3582507 - Comparative biochemical analysis of purified s-antigen from human, bovine, porcine and ...
2454667 - The new basement membrane antigen recognized by the monoclonal antibody gb3 is a large ...
16076527 - Identification of two highly performing leishmania infantum antigens for serodiagnosis ...
15647627 - New horizons in the analysis of circulating cell-derived microparticles.
21330177 - Antibody and t-cell responses during acute and convalescent stages of invasive pneumoco...
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-4
Journal Detail:
Title:  Expert opinion on biological therapy     Volume:  -     ISSN:  1744-7682     ISO Abbreviation:  Expert Opin Biol Ther     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101125414     Medline TA:  Expert Opin Biol Ther     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
University of Leuven, Laboratory for Therapeutic and Diagnostic Antibodies, Department of Pharmaceutical and Pharmacological Sciences , Campus GHB, ON2, PB 824, 3000 Leuven , Belgium +32 16 323431 ;
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Manganese-Catalyzed Aromatic C-H Alkenylation with Terminal Alkynes.
Next Document:  Hydration and Proton Transfer in Highly Sulfonated Poly(phenylene sulfone) Ionomers: An Ab Initio St...