JLE

Journal de Pharmacie Clinique

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Biopharmaceuticals and biosimilars: science and implications Volume 32, issue 1, Mars 2013

Author
Laboratoire d’anticorps thérapeutiques et diagnostiques, Faculté des sciences pharmaceutiques, Katholieke Universiteit Leuven, Leuven, Belgique

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. Pharmaceutical quality evaluation requires a complete dossier and a detailed comparative analysis to the reference drug. However, non-clinical and clinical requirements are much less extensive compared to the requirements for an innovator. Therefore at the time of introduction onto the market only limited clinical experience is available for the biosimilar. The complex nature excludes biosimilars from being considered interchangeable with the reference drug.