Biosimilars in Italy: a gastroenterologist's view

The introduction of biological therapy has revolutionized the paradigm of treatment in the last two decades. This is expected to lead to corresponding amelioration of the course of several immune-mediated diseases, including inflammatory bowel diseases (IBD). However, this may come with an appreciable increase in expenditure on drugs. Due to ongoing patent expiry of some biologicals, the introduction of biosimilars is creating the opportunity for substantial financial savings to be made, leading to easier, wider and earlier access to therapy for some patients, and possibly to changes in resource allocation by health services. However, the complexity and potential immunogenicity of the first monoclonal biosimilar of infliximab introduced to the market, and the extrapolation of its indications to all diseases approved for the originator, despite the absence of controlled trials in all diseases at time of market authorization, have initially raised concerns in the scientific community. In Italy, the uptake of this biosimilar (CT-P13) is already close to the European mean, although the utilization and regulation at regional levels is highly heterogeneous.