ABP 501 (adalimumab-atto) in the treatment of inflammatory bowel disease: an example of evidence-based extrapolation

Rev Esp Enferm Dig. 2021 Oct;113(10):737-738. doi: 10.17235/reed.2021.7921/2021.

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.

Publication types

  • Letter

MeSH terms

  • Adalimumab / therapeutic use
  • Biosimilar Pharmaceuticals* / therapeutic use
  • Colitis, Ulcerative*
  • Crohn Disease* / drug therapy
  • Humans
  • Inflammatory Bowel Diseases* / drug therapy

Substances

  • ABP 501
  • Biosimilar Pharmaceuticals
  • Adalimumab