1. Use of biosimilars in inflammatory bowel disease: Statements of the Italian Group for Inflammatory Bowel Disease
- Author
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Annese, V, Vecchi, M, on behalf of the Italian Group for the Study of, Ibd, Bossa, F, Calabrese, E, Daperno, M, Rizzello, F, Rispo, A, Saibeni, S, Armuzzi, A, Biancone, L, Castiglione, F, Comberlato, M, Cucchiara, S, Danese, S, D’Incà, R, Fiorino, G, Fries, W, Gionchetti, P, Kohn, A, Latella, Giovanni, Meucci, G, Orlando, A, Papi, C, Principi, B., M. Vecchi, V. Annese, behalf of the Italian Group for the Study of IBD, On, Bossa, IG IBD Governing B. o. a. r. d. Collaborators: F., Calabrese, E., Daperno, M., Rizzello, F., Rispo, A., Saibeni, S., Armuzzi, A., Biancone, L., Castiglione, F., Comberlato, M., Cucchiara, S., Danese, S., D'Incà, R., Gionata, Fiorino, Walter, Frie, Gionchetti, P., Kohn, A., Latella, G., Meucci, G., Orlando, A., Papi, C., Principi, B., Annese, V, Vecchi, M, Castiglione, Fabiana, on behalf of the Italian Group for the Study of, Ibd, IG IBD Governing, Board, Vito Annese, Maurizio Vecchi, on behalf of the Italian Group for the Study of IBD (IG-IBD) [.., Fabrizio Bossa, Emma Calabrese, Marco Daperno, Fernando Rizzello, Antonio Rispo, Simone Saibeni, Alessandro Armuzzi, Livia Biancone, Fabiana Castiglione, Michele Comberlato, Salvatore Cucchiara, Silvio Danese, Renata D’Incà, Gionata Fiorino, Walter Frie, Paolo Gionchetti, Anna Kohn, Giovanni Latella, Gimmy Meucci, Ambrogio Orlando, Claudio Papi, Beatrice Principi, and …]
- Subjects
Adult ,Male ,medicine.medical_specialty ,Settore MED/12 - GASTROENTEROLOGIA ,Guidelines as Topic ,Risk Assessment ,Gastroenterology ,Inflammatory bowel disease ,Anti-TNFα ,Gastrointestinal Agents ,Internal medicine ,medicine ,Humans ,Intensive care medicine ,Biosimilar Pharmaceuticals ,Drug Approval ,Societies, Medical ,Anti-TNFα, Biosimilars, Crohn's disease, Inflammatory bowel disease, Ulcerative colitis ,Biosimilars ,Ankylosing spondylitis ,Crohn's disease ,Gastrointestinal agent ,Hepatology ,business.industry ,Biosimilar ,Antibodies, Monoclonal ,Inflammatory Bowel Diseases ,medicine.disease ,Ulcerative colitis ,Infliximab ,Treatment Outcome ,Italy ,Rheumatoid arthritis ,Female ,business ,Follow-Up Studies ,Forecasting ,medicine.drug - 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.
- Published
- 2014