Gemeinsame Stellungnahme zum Beschluss des Gemeinsamen Bundesausschusses über die Einleitung eines Stellungnahme-Verfahrens zur Änderung der Arzneimittel-Richtlinie: § 40b (neu) – Austausch von biotechnologisch hergestellten biologischen Arzneimitteln durch Apotheken vom 15. Mai 2022

• Literatur

• 1 Hoivik 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 (04) 441-453
• 2 Hoivik ML, Moum B, Solberg IC. et al. Work disability in inflammatory bowel disease patients 10 years after disease onset: results from the IBSEN Study. Gut 2013; 62 (03) 368-375
• 3 European Medicines Agency: Guideline on similar biological medicinal products. 2014 http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC50017/6768.pdf
• 4 Jorgensen 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