Clinical and scientific aspects related to biosimilars in inflammatory bowel diseases (IBD) : position document of the Belgian IBD Research & Development Group (BIRD)

The management of chronic inflammatory disorders including inflammatory bowel diseases has been revolu- tionized by the entrance of biological agents now almost 20 years ago. Over 350 million of patients have been treated worldwide with biologicals. In Belgium, biologi- cals represent 26% of the total Belgian pharmaceutical budget both in the ambulatory settings and in the hospi- tals (53% are used in hospitals). In inflammatory bowel diseases (IBD), biological agents directed against TNF alpha are mainstay treatments for inducing and maintain- ing remission in moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). Three anti-TNF agents have been approved by EMA for use in Crohn's disease (infliximab and adalimumab) or ulcerative colitis (inflix- imab, adalimumab and golimumab). Eighteen years after the finalization of the pivotal trials, the patent for inflix- imab was the first to expire. Hence, biosimilars to inflix- imab are emerging on the market including for the treat- ment of IBD. Biosimilars are biological drugs which are similar to the authorized biologics ("reference product") but not identical. Recently EMA has approved 2 biosimi- lars to infliximab on the basis of a rigorous and extensive comparability exercise in all characteristics via a devel- opment programme that included quality, nonclinical and clinical data including two clinical trials in rheumatology (ankylosing spondylitis and rheumatoid arthritis) (1).