Year 2021 / Volume 113 / Number 10
Letter
ABP 501 (adalimumab-atto) in the treatment of inflammatory bowel disease: an example of evidence-based extrapolation

737-738

DOI: 10.17235/reed.2021.7921/2021

Fernando Muñoz Núñez, Carlos Taxonera, Jordi Marrón,

Abstract
We report the available evidence demonstrating the biosimilarity of ABP 501 (AMGEVITA®, adalimumab-atto) to its reference product (RP) (Humira®, adalimumab), and the rationale for the extrapolation of the results obtained with the RP in inflammatory bowel disease (IBD) to ABP 501. Based on its preclinical and clinical data, ABP 501 has been authorized for use in Europe in all the indications approved for the RP, including Crohn’s disease and ulcerative colitis.
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References
1 European Medicines Agency (EMA). AMGEVITA product information, https://www.ema.europa.eu/en/medicines/human/EPAR/amgevita; 2019
2 Halder S, Khan W, Wang X, et al. P071 Supporting extrapolation of indications for ABP 501, the first adalimumab biosimilar: focus on Crohn’s disease. J Crohns Colitis. 2019;13:S121. Doi: 10.1093/ecco-jcc/jjy222.195
3 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. Doi: 0.1093/ecco-jcc/jjw198
4 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. Rev Esp Enferm Dig. 2018;110:407. Doi: 10.4321/s1130-01082013000100006
5 Ribaldone DG, Caviglia GP, Pellicano R, et al. Effectiveness and safety of adalimumab biosimilar ABP 501 in Crohn's disease: an observational study. Rev Esp Enferm Dig. 2020;112 (3):195-200. Doi: 10.17235/reed.2020.6693/2019
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Muñoz Núñez F, Taxonera C, Marrón J. ABP 501 (adalimumab-atto) in the treatment of inflammatory bowel disease: an example of evidence-based extrapolation. 7921/2021


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Publication history

Received: 25/02/2021

Accepted: 27/02/2021

Online First: 02/03/2021

Published: 06/10/2021

Article Online First time: 5 days

Article editing time: 223 days


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