Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) |
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| Institution: | 1. Director of “Associazione nazionale per le Malattie Infiammatorie Croniche dell’Intestino” – A.M.I.C.I. ONLUS;2. President of “Associazione nazionale per le Malattie Infiammatorie Croniche dell’Intestino” – A.M.I.C.I. ONLUS;3. Pediatric Gastroenterology Unit, Department of Pediatrics and Childhood Neuropsychiatry, Umberto I Hospital –Sapienza University, Rome, Italy;4. Pediatric Gastroenterology Unit, Maggiore Hospital, Bologna, Italy;5. Gastroenterology Unit, Perugia General Hospital, Perugia, Italy;6. Department of Biochemical and Clinical Sciences “L. Sacco” – University of Milan, ASST Fatebenefratelli Sacco, Milan, Italy;7. Gastroenterology Unit, Department of General and Specialist Medicine, Città della Salute e della Scienza di Torino, Turin, Italy;8. Dipartimento di Medicina, Sez. Gastroenterolo-gia Ospedale di Perugia – Università di Perugia, Perugia, Italy;9. SOC Medicina Gastroenterologica/SOSD Degenza breve Internistica e Centro MICI Arcispedale S. Maria Nuova – IRCCS, Reggio Emilia, Italy;10. Gastroenterology Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy;11. IBD Section, Gastroenterology Unit, Departmentof Internal Medicine, University of Genoa, Genoa, Italy;12. Gastroenterology Unit, S. Maria del Prato Hospital, Feltre, Italy;13. UOC di Gastroenterologia ed Endoscopia Digestiva Ospedale Casa Sollievo della sofferenza IRCCS – San Giovanni Rotondo, Italy;14. UO Epatogastroenterologia e Nutrizione, Ospedale Pediatrico Bambino Gesù, Rome, Italy;15. Gastroenterology Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy;16. Ambulatorio IBD, UOC Gastroenterologia ed Epatologia Policlinico di Palermo, Palermo, Italy;17. Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine “Federico II” of Naples, Naples, Italy;18. Gastroenterologia AOU San Giovanni di Dio e Ruggi, Dipartimento di Medicina, Chirurgia e Odontoiatria, Scuola Medica Salernitana, Università di Salerno, Salerno, Italy;19. UOC of Gastroenterology and Digestive Endoscopy, University “Campus Bio Medico di Roma”, Rome, Italy;20. Gastroenterology Unit, Department ofMedicine, AOUI Policlinico G.B. Rossi & University of Verona, Verona, Italy;21. Department of Gastroenterology and Digestive Endoscopy Central Hospital, Bolzano, Italy;22. SC di Gastroenterologia ed Endoscopia Digestiva ASST Settelaghi – Varese, Italy;23. UOS M.I.C.I, UOC Gastroenterologia ed Endoscopia Digestiva diagnostica ed operativa, A.O San Camillo-Forlanini, Rome, Italy;24. U.O.C. di Gastroenterologia Universitaria –AOUP, Pisa, Italy;25. UOSD Malattie Intestinali Croniche, Dipar-timento di Medicina Clinica e Sperimentale, Università di Messina, Messina, Italy;26. Pediatric Gastroenterology, Liver and Digestive Endoscopy Unit, Department of Pediatrics and Childhood Neuropsychiatry, Umberto I Hospital – Sapienza University, Rome, Italy;27. UOD Gastroenterologia ed Endoscopia Digestiva, DEA I Livello Umberto I, Nocera Inferiore, Italy;28. US Malattie Infiammatorie Cronichedell’Intestino, UOC Gastroenterologia, Azienda Ospedaliera di Padova, Padua, Italy;29. UOC Gastroenterologia ed Endoscopia Digestiva, Azienda Ospedaliera San Giovanni Addolorata, Rome, Italy;30. First Department of Medicine, San Matteo Hospital Foundation, University of Pavia, Pavia, Italy;31. Clinica di Gastroenterologia, UniversitàPolitecnica delle Marche, Ancona, Italy;32. UOSD, Gastroenterologia D.U. – PO L’Aquila,Università degli Studi dell’Aquila, L’Aquila, Italy;33. UOSD Malattie Intestinali Croniche, Dipartimentodi Medicina Clinica e Sperimentale, Università di Messina, Messina, Italy;34. Direttore Area Gastroenterologia e Oncologia, Fondazione Policlinico Universitario A, Gemelli IRCCS –Università Cattolica del Sacro Cuore, Rome, Italy;35. UOC Gastroenterologia- IBD Unit-IRCCS Ospedale Sacro Cuore Don Calabria, Negrar, Italy;36. IBD Unit, DIMEC, University of Bologna, Bologna, Italy;37. UOC Gastroenterologia ed Endoscopia Digestiva, Azienda Ospedaliera San Giovanni Addolorata, Rome, Italy;38. Scienze Digestive Ospedale Spirito Santo Pescara, Università G. d’Annunzio Chieti-Pescara, Italy;39. UOS Day Hospital, UOC Medicina Interna e Malattiedell’Apparato Digerente, Presidio Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS – Università Cattolica del Sacro Cuore, Rome, Italy;40. DUOS Malattie Infiammatorie Croniche Intestinali, Gastroenterologia, Ospedale Valduce, Como, Italy;41. Gastroenterology Unit, Department of Life, Health and Environmental Sciences, University of L’Aquila, L’Aquila, Italy;42. Department NEUROFARBA, University of Florence, Gastroenterology and Nutrition Unit, Meyer Children’s Hospital, Florence, Italy;43. Dipartimento di Medicina Clinica e Sperimentale, Università di Catania, Catania, Italy;44. Gastroenterology Unit, Department of Biochemical and Clinical Science “L. Sacco” – University of Milan ASST Fatebenefratelli Sacco – Milan, Italy;45. UOC di Gastroenterologia, A.O.A. Cardarellidi Napoli, Naples, Italy;46. Department for Gastroenterology and Digestive Endoscopy, Academic Center of Udine, Udine, Italy;47. IBD Unit, UOC Gastroenterologia 2, IRCCS“S. De Bellis”, Castellana Grotte, Italy;48. UOC Gastroenterologia e Nutrizione, Ospedale San Nicola Pellegrino, Trani, Italy;49. UO di Gastroenterologia ed Endoscopia Digestiva, Ospedale San Giuseppe, Milan, Italy;50. Division of Gastroenterology, Ospedale Ordine Mauriziano di Torino, Turin, Italy;51. Centro di Riferimento Regionale Malattie Infiammatorie Croniche Intestinali, SOD Gastroenterologia Clinica, AOU Careggi, Florence, Italy;52. SC Gastroenterologia, Ospedale Brotzu, Cagliari, Italy;53. Gastroenterology Unit, Department of Systems Medicine, Tor Vergata University, Rome, Italy;54. Gastroenterology Unit, Ulss 12 Serenissima, Venice, Italy;55. UOC Gastroenterologia ed Endoscopia Digestiva, Azienda Ospedaliera San Giovanni Addolorata, Rome, Italy;56. Gastroenterology Unit, IRCCS Policlinico San Donato, San Donato Milanese, Italy;57. Centro MICI, UOS Gastroenterologia Territoriale, Ospedale Sandro Pertini, Rome, Italy;58. Gastroenterology and Digestive Endoscopy Unit, “Murri” Hospital, Polytechnic University of Marche, Fermo, Italy;59. IBD Unit, Azienda Ospedaliera perl’Emergenza “Cannizzaro”, Catania, Italy;60. IBD Unit, “Villa Sofia-Cervello” Hospital, Palermo, Italy;61. Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy;62. Gastroenterology Section, 1st Medical Clinic, Spedali Civili and University of Brescia, Brescia, Italy;63. Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine “Federico II” of Naples, Naples, Italy;64. Division of Gastroenterology, Ospedale Ordine Mauriziano di Torino, Turin, Italy;65. Pediatric Gastroenterology Unit, Department, “G. Martino’s Hospital”, University of Messina, Messina, Italy;66. Dipartimento di Medicina di Precisione ed UP diEndoscopia e Patologie Infiammatorie Croniche Gastrointestinali, Università della Campania ‘Luigi Vanvitelli’ ed Azienda Ospedaliera Universitaria, Naples, Italy;67. Gastroenterologia ed Endoscopia Digestiva, ASL di Spezzino, La Spezia, Italy;68. IBD Unit, SC Gastroenterologia, AAS5-Friuli Occidentale – Ospedale di Pordenone, Pordenone, Italy;69. Gastroenterolgy Unit, Rho Hospital, ASST Rho-dense, Rho, Italy;70. Department of Surgery, Oncology and Gastroenterology – DiSCOG, University of Padua, Padua, Italy;71. UOC Gastroenterologia ed Endoscopia Digestiva Diagnostica e Operativa, A.O. San Camillo-Forlanini, Rome, Italy;72. IBD Unit, Dipartimento di “Scienze Mediche e Chirurgiche”, Magna Graecia University, Catanzaro, Italy;73. Gastroenterology and Digestive Endoscopy, National Institute of Gastroenterology, “S. De Bellis” Research Hospital, Castellana Grotte, Italy;74. UOC Gastroenterologia ed Endoscopia Digestiva – ASST Ovest Milanese, Legnano, Italy;75. Gastroenterology, Department of Clinical Medicine and Surgery, Federico II School of Medicine, Naples, Italy;76. U.O. Gastroenterologia ed Endoscopia digestiva, Azienda Romagna Ospedale di Forlì, Forlì, Italy;77. UOC Gastroenterologia- IBD Unit-IRCCSO spedale Sacro Cuore Don Calabria, Negrar, Italy;78. Gastroenterology Unit, Sapienza University of Rome, Rome, Italy;79. UOC Gastroenterologia e Endoscopia Digestiva, Azienda Ospedaliera Regionale ‘San Carlo’, Potenza, Italy;80. Direttore Dipartimento di Medicina e Medicina Interna, Centro per la Diagnosi e Cura Malattie dell’ Intestino, Ospedale SS. Annunziata, Via Vicini 2, Cento, Italy;1. IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Rozzano, Italy;2. Department of Biomedical Sciences, Humanitas University, Rozzano, Italy;3. Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy, and Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano, Milan, Italy;4. Division of Gastroenterology, Ospedale Ordine Mauriziano di Torino, Turin, Italy;5. Gastroenterology and Endoscopy Unit, A.R.N.A.S Civico-Di Cristina-Benfratelli Hospital, Palermo, Italy;6. Gastroenterology Unit, Department of Organ Transplantation (DETO), Policlinico Universitario, Bari, Italy;7. Department of Life, Health and Environmental Sciences, University of L''Aquila, L''Aquila, Italy;8. Department of Systems Medicine, Tor Vergata University of Rome, Rome, Italy;9. IBD Unit, A.O. Osp. Riuniti “Villa Sofia-Cervello”, Palermo, Italy;10. IBD Unit, San Filippo Neri Hospital, Rome, Italy;11. IG-IBD member, Florence, Italy;12. IBD Unit, DIMEC, University of Bologna, Bologna, Italy;13. IBD Unit, Presidio Columbus, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy;14. Università Cattolica del Sacro Cuore, Rome, Italy |
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| Abstract: | The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars. |
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| Keywords: | Anti-TNFα Biosimilars Crohn’s disease Inflammatory bowel disease Tumor necrosis factor alpha Ulcerative colitis |
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