: 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.

Use of biosimilars in inflammatory bowel disease: a position update of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) / Fiorino, G; Caprioli, F; Daperno, M; Mocciaro, F; Principi, M; Viscido, A; Fantini, Mc; Orlando, A; Papi, C; Annese, V; Danese, S; Vecchi, M; Rizzello, F; Armuzzi, A; Leone, S; Previtali, E; Aloi, M; Alvisi, P; Antonelli, E; Ardizzone, S; Astegiano, M; Baldoni, M; Beltrami, M; Biancone, L; Bodini, G; Buda, A; Bossa, F; Bracci, F; Calabrese, E; Cappello, M; Castiglione, F; Ciacci, C; Cicala, M; Ciccocioppo, R; Comberlato, M; Cortelezzi, Cc; Cosintino, R; Costa, F; Costantino, G; Cucchiara, S; Cuomo, A; D'Inca, R; Di Paolo, Mc; Di Sabatino, A; Di Sario, A; Frieri, G; Fries, W; Gasbarrini, A; Geccherle, A; Gionchetti, P; Graziani, Mg; Grossi, L; Guidi, L; Imperiali, G; Latella, G; Lionetti, P; Inserra, G; Maconi, G; Manguso, F; Marino, M; Mastronardi, M; Mazzuoli, S; Meucci, G; Mendolaro, M; Milla, M; Mocci, G; Monteleone, G; Bortoluzzi, Fn; Pagnini, C; Pastorelli, L; Pica, R; Piergallini, S; Privitera, A; Renna, S; Ribaldone, Dg; Ricci, C; Rispo, A; Rocca, R; Romano, C; Romano, M; Russo, G; Sablich, R; Saibeni, S; Savarino, E; Scribano, Ml; Spagnuolo, R; Stasi, E; Terpin, Mm; Testa, A; Valpiani, D; Variola, A; Vernia, P; Vitale, G; Zoli, G. - In: DIGESTIVE AND LIVER DISEASE. - ISSN 1590-8658. - 51:5(2019), pp. 632-639. [10.1016/j.dld.2019.02.004]

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

Annese V;Danese S;
2019-01-01

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.
2019
Anti-TNFα
Biosimilars
Crohn’s disease
Inflammatory bowel disease
Tumor necrosis factor alpha
Ulcerative colitis
File in questo prodotto:
File Dimensione Formato  
Use of biosimilars in inflammatory bowel disease a position update of the Italian Group for the Study of Inflammatory Bowel Disease IG-IBD.pdf

solo gestori archivio

Tipologia: PDF editoriale (versione pubblicata dall'editore)
Licenza: Copyright dell'editore
Dimensione 698.54 kB
Formato Adobe PDF
698.54 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/20.500.11768/119429
Citazioni
  • ???jsp.display-item.citation.pmc??? 15
  • Scopus 39
  • ???jsp.display-item.citation.isi??? 38
social impact