Biosimilars of adalimumab: the upcoming challenge in IBD

Expert Opin Biol Ther. 2019 Oct;19(10):1023-1030. doi: 10.1080/14712598.2019.1564033. Epub 2019 Jan 8.

Abstract

Introduction: Biosimilars represent great potential in cost saving and re-investment opportunities in healthcare and allow patients greater access to effective mAbs. Infliximab biosimilars are successfully used in all indications for whom the reference product (RP) was approved. Areas covered: In late 2018, adalimumab biosimilars will also be available in patients with inflammatory bowel disease (IBD). ABP501, BI 695501, GP2017, and SB5 have been approved by the EMA for the same indications of the reference product (RP, Humira®). Preclinical data show high similarity between all biosimilars and the RP. Clinical data in patients with rheumatoid arthritis and psoriasis also show no differences in terms of efficacy, safety, and immunogenicity. Data in IBD patients are still lacking. Expert opinion: Biosimilars of adalimumab appear to be clinically equivalent to the RP. Decisions based on choosing the ideal patient to receive or to be switched to a biosimilar of adalimumab, or choosing one biosimilar vs. another, or cross-switching among biosimilars remain the next challenge in the field of IBD.

Keywords: Adalimumab; Crohn’s disease; biosimilar; inflammatory bowel disease; ulcerative colitis.

Publication types

  • Review

MeSH terms

  • Adalimumab / chemistry*
  • Adalimumab / therapeutic use
  • Antibodies, Monoclonal / chemistry
  • Antibodies, Monoclonal / metabolism
  • Antibodies, Monoclonal / therapeutic use*
  • Biosimilar Pharmaceuticals / chemistry
  • Biosimilar Pharmaceuticals / metabolism
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Clinical Trials as Topic
  • Half-Life
  • Humans
  • Inflammatory Bowel Diseases / drug therapy*
  • Infliximab / chemistry

Substances

  • Antibodies, Monoclonal
  • BI 695501
  • Biosimilar Pharmaceuticals
  • GP2017
  • Infliximab
  • Adalimumab