THE DILEMMAS AND CHALLENGES IN THE PHARMACOVIGILANCE OF BIOLOGICAL MEDICINES IN BRAZIL

Abstract

With the arrival to the market of biosimilar medicines, there is a great expectation in all sectors of the healthcare system for a greater competitiveness in terms of costs for the treatment of chronic and oncological diseases that benefit from this class of drugs. However, from the clinical impact point of view, there are still many questions not necessarily related to the efficacy of biosimilar medicines, since it was demonstrated by the own studies undertaken prior to approval, but especially related to security in the alternated use between reference and biosimilar medicines, the interchangeability. As if not enough challenges that are already exposed the pharmacovigilance system, such a situation of interchangeability between biological medicines generates an even greater need to create efficient traceability mechanisms of these non-identical and known immunogenic proteins.