Title: Biosimilar monoclonal antibodies: a science-based regulatory challenge
Authors: Declerck, Paul # ×
Issue Date: Jan-2013
Publisher: Ashley Publications Ltd.
Series Title: Expert Opinion on Biological Therapy vol:13 issue:2 pages:153-156
Abstract: 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 Taking into account the expected high development costs for biosimilar MAs, their use may well be superseded by alternative antibody formats and next-generation MAs.
ISSN: 1471-2598
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory for Pharmaceutical Biology (-)
× corresponding author
# (joint) last author

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