References
- Lakatos L, Kiss LS, David G, et al. Incidence, disease phenotype at diagnosis, and early disease course in inflammatory bowel diseases in Western Hungary, 2002-2006. Inflamm Bowel Dis. 2011;17:2558–2565.
- Burisch J, Jess T, Martinato M, et al. The burden of inflammatory bowel disease in Europe. J Crohns Colitis. 2013;7:322–337.
- Cai Z, Wang S, Li J. Treatment of inflammatory bowel disease: a comprehensive review. Front Med. 2021;8:765474.
- Torres J, Bonovas S, Doherty G, et al. ECCO guidelines on therapeutics in Crohn’s disease: medical treatment. J Crohns Colitis. 2020;14:4–22.
- Harbord M, Eliakim R, Bettenworth D, et al. Third European evidence-based consensus on diagnosis and management of Ulcerative Colitis. Part 2: current management. J Crohns Colitis. 2017;11:769–784.
- Derkx B, Taminiau J, Radema S, et al. Tumour-necrosis-factor antibody treatment in Crohn’s disease. Lancet Lond Engl. 1993;342:173–174.
- Targan SR, Hanauer SB, van Deventer SJ, et al. A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease. Crohn’s disease cA2 study group. N Engl J Med. 1997;337:1029–1035.
- Abraham J. Developing oncology biosimilars: an essential approach for the future. Semin Oncol. 2013;40:S5–24.
- European Medicines Agency. European medicines agency recommends approval of first two monoclonal-antibody biosimilars [Internet]. Eur. Med. Agency. 2013 [cited 2022 Nov 27]. Available from: https://www.ema.europa.eu/en/news/european-medicines-agency-recommends-approval-first-two-monoclonal-antibody-biosimilars.
- European Medicines Agency. Meeting highlights from the committee for medicinal products human use (CHMP) [Internet]. Eur. Med. Agency. 2017 [cited 2022 Nov 27]. Available from: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-january-2017.
- Fleischmann R, Jairath V, Mysler E, et al. Nonmedical switching from originators to biosimilars: does the nocebo effect explain treatment failures and adverse events in rheumatology and gastroenterology? Rheumatol Ther. 2020;7:35–64.
- McKinnon RA, Cook M, Liauw W, et al. Biosimilarity and interchangeability: principles and evidence: a systematic review. BioDrugs. 2018;32:27–52.
- Chavarria V, Vian J, Pereira C, et al. The placebo and nocebo phenomena: their clinical management and impact on treatment outcomes. Clin Ther. 2017;39:477–486.
- Mazzoni D, Vener C, Mazzocco K, et al. The psychological risks associated with the non-medical switch from biologics to biosimilars. Front Psychol. 2021;12:1–4.
- Bodger K, Ormerod C, Shackcloth D, et al. Development and validation of a rapid, generic measure of disease control from the patient’s perspective: the IBD-control questionnaire. Gut. 2014;63:1092–1102.
- Stavem K. Switching from one reference biological to another in stable patients for non-medical reasons: a literature search and brief review. J Mark Access Health Policy. 2021;9:1964792.
- Martelli L, Peyrin-Biroulet PBL. Efficacy, safety and immunogenicity of biosimilars in inflammatory bowel diseases: a systematic review. Curr Med Chem. 2019;26:270–279.
- Gecse KB, Lovász BD, Farkas K, et al. Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort. J Crohn Colitis. 2016;10:133–140.
- Kamat N, Kedia S, Ghoshal UC, et al. Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: a multicenter study. Indian J Gastroenterol off J Indian Soc Gastroenterol. 2019;38:44–54.
- Nguyen E, Weeda ER, Sobieraj DM, et al. Impact of non-medical switching on clinical and economic outcomes, resource utilization and medication-taking behavior: a systematic literature review. Curr Med Res Opin. 2016;32:1281–1290.
- Jørgensen KK, Olsen IC, Goll GL, et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet. 2017;389:2304–2316.
- Hanauer S, Liedert B, Balser S, et al. Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn’s disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021;6:816–825.
- Odinet JS, Day CE, Cruz JL, et al. The biosimilar nocebo effect? A systematic review of double-blinded versus open-label studies. J Manag Care Spec Pharm. 2018;24:952–959.
- Boone NW, Liu L, Romberg-Camps MJ, et al. The nocebo effect challenges the non-medical infliximab switch in practice. Eur J Clin Pharmacol. 2018;74:655–661.
- Planès S, Villier C, Mallaret M. The nocebo effect of drugs. Pharmacol Res Perspect. 2016;4:e00208.
- St Clair-Jones A, Prignano F, Goncalves J, et al. Understanding and minimising injection-site pain following subcutaneous administration of biologics: a narrative review. Rheumatol Ther. 2020;7:741–757.
- Coghlan J, He H, Schwendeman AS. Overview of humira® biosimilars: current European landscape and future implications. J Pharm Sci. 2021;110:1572–1582.
- García-Beloso N, Altabás-González I, Samartín-Ucha M, et al. Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: a systematic literature review. Br J Clin Pharmacol. 2022;88:1529–1550.
- Gonczi L, Lakatos PL. Can we say no to the “Nocebo effect” in inflammatory bowel diseases? J Crohns Colitis. 2019;13:1095–1096.
- Danese S, Fiorino G, Raine T, et al. ECCO position statement on the use of biosimilars for inflammatory bowel disease—an update. J Crohns Colitis. 2017;11:26–34.
- Peyrin-Biroulet L, Danese S, Cummings F, et al. Anti-TNF biosimilars in Crohn’s disease: a patient-centric interdisciplinary approach. Expert Rev Gastroenterol Hepatol. 2019;13:731–738.
- Tapete G, Bertani L, Pieraccini A, et al. Effectiveness and safety of nonmedical switch from adalimumab originator to SB5 biosimilar in patients with inflammatory bowel diseases: twelve-month follow-up from the TABLET registry. Inflamm Bowel Dis. 2022;28:62–69.
- Tursi A, Mocci G, Cuomo A, et al. Replacement of adalimumab originator to adalimumab biosimilar for a non-medical reason in patients with inflammatory bowel disease: a real-life comparison of adalimumab biosimilars currently available in Italy. J Gastrointest Liver Dis. 2022;31:411–416.