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 Taking into account the expected high development costs for biosimilar MAs, their use may well be superseded by alternative antibody formats and next-generation MAs.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
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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 ;
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