Correlation Engine 2.0
Clear Search sequence regions

Sizes of these terms reflect their relevance to your search.

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 Taking into account the expected high development costs for biosimilar MAs, their use may well be superseded by alternative antibody formats and next-generation MAs.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. Biosimilar monoclonal antibodies: a science-based regulatory challenge. Expert opinion on biological therapy. 2013 Feb;13(2):153-6

Expand section icon Mesh Tags

Expand section icon Substances

PMID: 23286777

View Full Text