Title: Biologicals and biosimilars: a review of the science and its implications
Authors: Declerck, Paul # ×
Issue Date: Mar-2012
Publisher: Generics and Biosimilars Initiative
Series Title: GaBI - Generics and Biosimilars Initiative Journal vol:1 issue:1 pages:13-16
Abstract: Biopharmaceuticals are medicines whose active drug substance is made by living cells. Copies of these drugs, called biosimilars, are not identical to their reference drug and therefore specific regulatory requirements for registration apply. Whereas pharmaceutical quality evaluation requires a full dossier and a detailed comparative analysis to the reference drug, non-clinical and clinical requirements are much less extensive compared to the requirements for an innovator. Limited clinical experience and their complex nature exclude biosimilars from being considered interchangeable with the reference drug.
ISSN: 2033-6403
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory for Pharmaceutical Biology (-)
× corresponding author
# (joint) last author

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