Biologicals and biosimilars: a review of the science and its implications
Journal Title: Generics and Biosimilars Initiative Journal - Year 2012, Vol 1, Issue 1
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.
Authors and Affiliations
Paul J Declerck
Keywords
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- EP ID EP355188
- DOI 10.5639/gabij.2012.0101.005
- Views 134
- Downloads 0
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