More than twelve years have endorsed biosimilar medicines, since the first of them was approved in Europe, in 2006. The European Union was a pioneer in the establishment of a regulatory framework for biosimilar medicines, which is constantly monitored and updated throughout the world. based on accumulated evidence. However, even though these drugs are not new to the therapeutic arsenal, the relatively recent arrival of monoclonal antibodies has opened up new usage scenarios that entail a paradigm shift.