Biosimilars: in support of extrapolation of indications

J Crohns Colitis. 2014 May;8(5):431-5. doi: 10.1016/j.crohns.2014.02.007. Epub 2014 Mar 1.


Biosimilars have the potential to lead to enormous cost savings in healthcare without reducing the level of care for patients. In Europe, biosimilars have to demonstrate comparability in an extensive biosimilarity exercise including analytical, preclinical and comparative clinical studies. By successfully completing the biosimilarity exercise, the biosimilar shows that all aspects that are considered relevant for the clinical activity of the product fall within the same range as observed for the innovator. It should be carefully considered whether the benefit of additional information from more comparative clinical studies weighs up to the additional barriers such studies create for biosimilars to enter clinical practice.

Keywords: Authorization; Biosimilar; Extrapolation; Infliximab; Safety; Tumor necrosis factor alpha.

MeSH terms

  • Antibodies, Monoclonal / economics
  • Antibodies, Monoclonal / therapeutic use
  • Biosimilar Pharmaceuticals / economics*
  • Europe
  • Evidence-Based Medicine
  • Gastrointestinal Agents / economics
  • Gastrointestinal Agents / therapeutic use
  • Humans
  • Inflammatory Bowel Diseases / drug therapy
  • Inflammatory Bowel Diseases / economics
  • Infliximab
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / economics


  • Antibodies, Monoclonal
  • Biosimilar Pharmaceuticals
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • Infliximab