Use of biosimilars in inflammatory bowel disease : a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved..

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.

Media Type:

Electronic Article

Year of Publication:

2019

Contained In:

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver - Vol. 51, No. 5 (2019), p. 632-639

Language:

English

Contributors:

Fiorino, Gionata
Caprioli, Flavio
Daperno, Marco
Mocciaro, Filippo
Principi, Mariabeatrice
Viscido, Angelo
Fantini, Massimo Claudio
Orlando, Ambrogio
Papi, Claudio
Annese, Vito
Danese, Silvio
Vecchi, Maurizio
Rizzello, Fernando
Armuzzi, Alessandro
National patients’ association representatives
Leone, Salvatore
Previtali, Enrica
Aloi, Marina
Alvisi, Patrizia
Antonelli, Elisabetta
Ardizzone, Sandro
Astegiano, Marco
Baldoni, Monia
Beltrami, Marina
Biancone, Livia
Bodini, Giorgia
Buda, Andrea
Bossa, Fabrizio
Bracci, Fiammetta
Calabrese, Emma
Cappello, Maria
Castiglione, Fabiana
Ciacci, Carolina
Cicala, Michele
Ciccocioppo, Rachele
Comberlato, Michele
Cortelezzi, Claudio Camillo
Cosintino, Rocco
Costa, Francesco
Costantino, Giuseppe
Cucchiara, Salvatore
Cuomo, Antonio
D'Incà, Renata
Di Paolo, Maria Carla
Di Sabatino, Antonio
Di Sario, Antonio
Frieri, Giuseppe
Fries, Walter
Gasbarrini, Antonio
Geccherle, Andrea
Gionchetti, Paolo
Graziani, Maria Giovanna
Grossi, Laurino
Guidi, Luisa
Imperiali, Gianni
Latella, Giovanni
Lionetti, Paolo
Inserra, Gaetano
Maconi, Giovanni
Manguso, Francesco
Marino, Marco
Mastronardi, Mauro
Mazzuoli, Silvia
Meucci, Gianmichele
Mendolaro, Marco
Milla, Monica
Mocci, Giammarco
Monteleone, Giovanni
Bortoluzzi, Francesco Neri
Pagnini, Cristiano
Pastorelli, Luca
Pica, Roberta
Piergallini, Simona
Privitera, Antonello
Renna, Sara
Ribaldone, Davide Giuseppe
Ricci, Chiara
Rispo, Antonio
Rocca, Rodolfo
Romano, Claudio
Romano, Marco
Russo, Giovanni
Sablich, Renato
Saibeni, Simone
Savarino, Edoardo
Scribano, Maria Lia
Spagnuolo, Rocco
Stasi, Elisa
Terpin, Maria Maddalena
Testa, Anna
Valpiani, Daniela
Variola, Angela
Vernia, Piero
Vitale, Giovanna
Zoli, Giorgio

Urls:

Volltext

Keywords:

Adalimumab
Anti-TNFα
Antibodies, Monoclonal
B72HH48FLU
Biosimilar Pharmaceuticals
Biosimilars
Crohn’s disease
FYS6T7F842
Humans
Inflammatory Bowel Diseases
Inflammatory bowel disease
Infliximab
Italy
Journal Article
Randomized Controlled Trials as Topic
Review
Societies, Medical
Tumor Necrosis Factor-alpha
Tumor necrosis factor alpha
Ulcerative colitis

Notes:

Date Completed 05.02.2020

Date Revised 31.10.2020

published: Print-Electronic

Citation Status MEDLINE

Copyright: From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Physical Description:

Online-Ressource

doi:

10.1016/j.dld.2019.02.004

PMID:

30872085

PPN (Catalogue-ID):

NLM295495073