Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).
Anti-TNFα
Biosimilars
Crohn’s disease
Inflammatory bowel disease
Tumor necrosis factor alpha
Ulcerative colitis
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
05 2019
05 2019
Historique:
received:
16
01
2019
revised:
03
02
2019
accepted:
04
02
2019
pubmed:
16
3
2019
medline:
6
2
2020
entrez:
16
3
2019
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 30872085
pii: S1590-8658(19)30067-2
doi: 10.1016/j.dld.2019.02.004
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Biosimilar Pharmaceuticals
0
Tumor Necrosis Factor-alpha
0
Infliximab
B72HH48FLU
Adalimumab
FYS6T7F842
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
632-639Investigateurs
Salvatore Leone
(S)
Enrica Previtali
(E)
Marina Aloi
(M)
Patrizia Alvisi
(P)
Elisabetta Antonelli
(E)
Sandro Ardizzone
(S)
Marco Astegiano
(M)
Monia Baldoni
(M)
Marina Beltrami
(M)
Livia Biancone
(L)
Giorgia Bodini
(G)
Andrea Buda
(A)
Fabrizio Bossa
(F)
Fiammetta Bracci
(F)
Emma Calabrese
(E)
Maria Cappello
(M)
Fabiana Castiglione
(F)
Carolina Ciacci
(C)
Michele Cicala
(M)
Rachele Ciccocioppo
(R)
Michele Comberlato
(M)
Claudio Camillo Cortelezzi
(CC)
Rocco Cosintino
(R)
Francesco Costa
(F)
Giuseppe Costantino
(G)
Salvatore Cucchiara
(S)
Antonio Cuomo
(A)
Renata D'Incà
(R)
Maria Carla Di Paolo
(MC)
Antonio Di Sabatino
(A)
Antonio Di Sario
(A)
Giuseppe Frieri
(G)
Walter Fries
(W)
Antonio Gasbarrini
(A)
Andrea Geccherle
(A)
Paolo Gionchetti
(P)
Maria Giovanna Graziani
(MG)
Laurino Grossi
(L)
Luisa Guidi
(L)
Gianni Imperiali
(G)
Giovanni Latella
(G)
Paolo Lionetti
(P)
Gaetano Inserra
(G)
Giovanni Maconi
(G)
Francesco Manguso
(F)
Marco Marino
(M)
Mauro Mastronardi
(M)
Silvia Mazzuoli
(S)
Gianmichele Meucci
(G)
Marco Mendolaro
(M)
Monica Milla
(M)
Giammarco Mocci
(G)
Giovanni Monteleone
(G)
Francesco Neri Bortoluzzi
(FN)
Cristiano Pagnini
(C)
Luca Pastorelli
(L)
Roberta Pica
(R)
Simona Piergallini
(S)
Antonello Privitera
(A)
Sara Renna
(S)
Davide Giuseppe Ribaldone
(DG)
Chiara Ricci
(C)
Antonio Rispo
(A)
Rodolfo Rocca
(R)
Claudio Romano
(C)
Marco Romano
(M)
Giovanni Russo
(G)
Renato Sablich
(R)
Simone Saibeni
(S)
Edoardo Savarino
(E)
Maria Lia Scribano
(ML)
Rocco Spagnuolo
(R)
Elisa Stasi
(E)
Maria Maddalena Terpin
(MM)
Anna Testa
(A)
Daniela Valpiani
(D)
Angela Variola
(A)
Piero Vernia
(P)
Giovanna Vitale
(G)
Giorgio Zoli
(G)
Informations de copyright
Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.