Zeitschrift für Gastroenterologie, Table of Contents Z Gastroenterol 2020; 58(05): 472-476DOI: 10.1055/a-1159-8202 Mitteilungen der DGVS Stellungnahme zur Änderung der Arzneimittel-Richtlinie: Austausch von biotechnologisch hergestellten biologischen Arzneimitteln – 17. März 2020 Recommend Article Abstract Buy Article Full Text References Literatur 1 Høivik ML, Bernklev T, Solberg IC. et al Patients with Crohn's disease experience reduced general health and vitality in the chronic stage: ten-year results from the IBSEN study. J Crohns Colitis 2012; 6: 441-453 . doi: 10.1016/j.crohns.2011.10.001. Epub 2011 Nov 9 2 Høivik ML, Moum B, Solberg IC. IBSEN Group. et al Work disability in inflammatory bowel disease patients 10 years after disease onset: results from the IBSEN Study. Gut 2013; 62: 368-375 . doi: 10.1136/gutjnl-2012-302311. Epub 2012 Jun 20 3 European Medicines Agency. Guideline on similar biological medicinal products, Oct 23, 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf 4 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 . doi:10.1016/S0140-6736(17)30068-5 5 Yoo DH. et al. Ann Rheum Dis 2013; 72: 1613-1620 6 Park W. et al. Ann Rheum Dis 2013; 72: 1605-1612 7 Ye BD, Pesegova M, Alexeeva O. et al Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet 2019; 393: 1699-1707 . doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28 8 Blauvelt A, LAcour JP, Fowler Jr JF. et al Phase III randomized study of the proposed adalimumab biosimilar GP2017 in psoriasis: impact of multiple switches. Br J Dermatol 2018; 179: 623-631 . doi:10.1111/bjd.16890
