Rheumatic Diseases and Biosimilars: Evidence about Switch from Originators to Biosimilars in the Real Life

Abstract

Biosimilars are broadly available for the treatment of several diseases including inflammatory arthritis. Thanks to biosimilars it has been possible to treat a greater number of rheumatic patients who previously were undertreated due to the high cost of originators, in several countries. There are a lot of data from double blind, randomized, controlled clinical trials, especially on TNF inhibitors (TNFi), concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe mainly for economic reasons. However, despite the considerable saving, such shifts to biosimilar drugs are still being debated, principally over their ethical implications. Since the drugs are similar but not identical, the main issues are related to the possibility to compare the adverse events and/or the lack of efficacy and, to date, the variability in effectiveness for a single patient remains an unpredictable datum before effecting the switch. Despite encouraging data about the maintenance of efficacy and safety after the switch, there are many reports of discontinuation due both lack of efficacy or and adverse events. In this chapter we aim at showing the disease activity trend and the safety after the transition to TNF-i biosimilars in patients with rheumatic diseases in real life..