TY - JOUR T1 - Biosimilars: A New Scenario in Biologic Therapies JO - Reumatología Clínica (English Edition) T2 - AU - Serra López-Matencio,José M. AU - Morell Baladrón,Alberto AU - Castañeda,Santos SN - 21735743 M3 - 10.1016/j.reumae.2016.05.014 DO - 10.1016/j.reumae.2016.05.014 UR - https://reumatologiaclinica.org/en-biosimilars-a-new-scenario-in-articulo-S217357431730103X AB - There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events. ER -