title: Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease.
abstract: The introduction of biological therapies, particularly anti-TNFα agents, has revolutionized the management 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 the market. In September 2013, the European Medicines Agency approved two infliximab biosimilars for treatment of adult and paediatric inflammatory bowel disease patients, a decision based largely on efficacy 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 between biosimilars and reference biologics are cause for concern. In the present paper, the Italian Group for inflammatory bowel disease presents its statements on these issues, with emphasis on the peculiar clinical characteristics of inflammatory bowel disease and the importance of providing physicians and patients with adequate information and guarantees on the safety and efficacy of these new drugs in the specific setting of inflammatory bowel disease.
authors.affiliation: Department of Medical and Surgical Specialties, Gastroenterology, AOU University Hospital Careggi, Florence, Italy. Electronic address: annesev@aou-careggi.toscana.it.
authors.forename: Vito
authors.initials: V
authors.lastname: Annese
authors.affiliation: University of Milan, Department of Biomedical Sciences for Health, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy. Electronic address: maurizio.vecchi@unimi.it.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Vecchi
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology / Q000627:therapeutic use*; D017277:Drug Approval; D005260:Female; D005500:Follow-Up Studies; D005544:Forecasting; D005765:Gastrointestinal Agents / Q000627:therapeutic use; D017408:Guidelines as Topic; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000175:diagnosis / Q000188:drug therapy*; D000069285:Infliximab; D007558:Italy; D008297:Male; D018570:Risk Assessment; D012955:Societies, Medical; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals; D005765:Gastrointestinal Agents; D000069285:Infliximab
keywords: Anti-TNFα; Biosimilars; Crohn's disease; Inflammatory bowel disease; Ulcerative colitis