Format

Send to

Choose Destination
Dig Liver Dis. 2014 Nov;46(11):963-8. doi: 10.1016/j.dld.2014.07.019. Epub 2014 Aug 17.

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

Author information

1
Department of Medical and Surgical Specialties, Gastroenterology, AOU University Hospital Careggi, Florence, Italy. Electronic address: annesev@aou-careggi.toscana.it.
2
University of Milan, Department of Biomedical Sciences for Health, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy. Electronic address: maurizio.vecchi@unimi.it.
3
Division of Gastroenterology, IRCCS-CSS Hospital, San Giovanni Rotondo, Italy.
4
Gastroenterology Unit, Department of Systems Medicine, University of Rome Tor Vergata, Italy.
5
Gastroenterology Unit, AO Ordine Mauriziano, Torino, Italy.
6
IBD Unit, Dept of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
7
Gastroenterology, Department of Clinical Medicine and Surgery, A.O.U. "Federico II" of Naples, Italy.
8
Gastroenterology, Azienda Ospedaliera Guido Salvini, Hospital Rho, Milan, Italy.
9
IBD Unit, Columbus Clinic and Catholic University of Rome, Rome, Italy.
10
GI Unit, Department of Systems Medicine, University of Tor Vergata, Rome, Italy.
11
Division of Gastroenterology, Regional Hospital, Bolzano, Italy.
12
Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy.
13
IBD Center, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Milan, Italy.
14
Division of Gastroenterology, DISCoG, University of Padua, Italy.
15
Clinical Unit of Chronic Bowel Disorders, Dept. of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
16
IBD Unit, Dept. of Medical and Surgical Sciences, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
17
Division of Gastroenterology, AO San Camillo Forlanini, Rome, Italy.
18
Department of Life, Health and Environmental Sciences, Gastroenterology Unit, University of L
19
Unit of Gastroenterology and Endoscopy, San Giuseppe Hospital, Milan, Italy.
20
Unit of Medicin 2°, A.O. "Villa Sofia-Cervello" Hospitals, Palermo, Italy.
21
Gastroenterology and Hepatology Unit S Filippo Neri Hospital, Rome, Italy.
22
Gastroenterology Unit (D.E.T.O.), University of Bari, Bari, Italy.

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.

KEYWORDS:

Anti-TNFα; Biosimilars; Crohn's disease; Inflammatory bowel disease; Ulcerative colitis

PMID:
25139379
DOI:
10.1016/j.dld.2014.07.019
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center