Consideraciones Regulatorias sobre Productos Biológicos en Brasil

AbstractBiosimilars are biologics developed to compete with originator biologics that have been on the market for a long time and lost their patent and market protection. The WHO guidelines on evaluation of Biosimilars provide clear guidance for regulators on how to develop and gain approval for these products. The aim of this paper is to inform of the current status of development in regulation of Biosimilars in Brazil according WHO Guidelines.The result of the comparison shows the Brazilian regulation conflicts with the principles of the WHO guidelines