Year 2021 / Volume 113 / Number 10
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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

Fernando Muñoz Núñez, Carlos Taxonera, Jordi Marrón,

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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Asociación Española de Ecografía Digestiva Sociedad Española de Endoscopia Digestiva Sociedad Española de Patología Digestiva
The Spanish Journal of Gastroenterology is the official organ of the Sociedad Española de Patología Digestiva, the Sociedad Española de Endoscopia Digestiva and the Asociación Española de Ecografía Digestiva
© 2021 The Spanish Journal of Gastroenterology