Medicamentos Biotecnológicos: Requisitos Exigidos para el Desarrollo y Aprobación de Biosimilares.

This article reviews the European guidelines on drugs comparability that establish the methodology for verifying biosimilarity between the so-called biosimilar drugs and the reference biological medicinal product. Biosimilars are biological medicines similar but not identical to the original drugs and can be manufactured by any laboratory after the expiration of biotech drugs patent. The guidelines of the European Medicines Agency (EMA) and the International Conference on Harmonization (ICH) that must be considered in the development and approval of these drugs also are reviewed. It is shown that biosimilars cannot be considered as generic drugs, being necessary to conduct additional assays prior to obtain marketing authorization. [ABSTRACT FROM AUTHOR]