Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease.

tThe introduction of biological therapies, particularly anti-TNF agents, has revolutionized the manage-ment of inflammatory bowel disease in those cases which are refractory to conventional treatment;however these drugs are not risk-free and their use has substantially increased the cost of treatment.As marketing protection expires for original, first-generation biopharmaceuticals, lower-cost “copies”of these drugs produced by competitor companies—referred to as biosimilars—are already entering themarket. In September 2013, the European Medicines Agency approved two infliximab biosimilars fortreatment of adult and paediatric inflammatory bowel disease patients, a decision based largely on effi-cacy and safety data generated in studies of patients with ankylosing spondylitis and rheumatoid arthritis.For many clinicians, extrapolation practices and the general question of interchangeability betweenbiosimilars and reference biologics are cause for concern. In the present paper, the Italian Group forinflammatory bowel disease presents its statements on these issues, with emphasis on the peculiar clini-cal characteristics of inflammatory bowel disease and the importance of providing physicians and patientswith adequate information and guarantees on the safety and efficacy of these new drugs in the specificsetting of inflammatory bowel disease.