Year 2018 / Volume 110 / Number 6
Letter to the Editor
Update of the SEPD position statement on the use of biosimilars for inflammatory bowel disease

407

DOI: 10.17235/reed.2018.5456/2018

Federico Argüelles Arias, Joaquín Hinojosa del Val, Isabel Vera Mendoza,

Abstract
In 2013, the European Medicines Agency (EMA) approved the biosimilar infliximab (CT-P13) for the full range of indications of the originator product, based on data from two trials conducted in rheumatoid arthritis and ankylosing spondylitis. The same year, our Society published a position statement that was later reviewed.
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References
1. European Medicines Agency. CHMP assessment report Remsima [EMA/CHMP/589317/2013]. London: EMA, 201
2. Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, et al. Joint position statement by “Sociedad Española de Patología Digestiva” (Spanish Society of Gastroenterology) and “Sociedad Española de Farmacología” (Spanish Society of Pharmacology) on biosimilar therapy for inflammatory bowel disease. Rev Esp Enferm Dig. 2013; 105(1):37-43.
3. Argüelles-Arias F, Barreiro-de-Acosta M, Carballo F, et al. New contributions to consensus on biosimilars. Rev Esp Enferm Dig. 2014; 106(3): 228-9.
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(10086): 2304-2316. doi: 10.1016/S0140-6736(17)30068-5.
5. 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(1): 26-34. doi: 10.1093/ecco-jcc/jjw198.
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Argüelles Arias F, Hinojosa del Val J, Vera Mendoza I. Update of the SEPD position statement on the use of biosimilars for inflammatory bowel disease . 5456/2018


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Publication history

Received: 07/01/2018

Accepted: 15/01/2018

Online First: 12/03/2018

Published: 31/05/2018

Article Online First time: 64 days

Article editing time: 144 days


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