Biosimilars: how similar?

Intern Med J. 2014 Mar;44(3):218-23. doi: 10.1111/imj.12292.


As patents expire on biological agents for the treatment of rheumatic diseases, we have the opportunity to develop non-proprietary biologic agents, biosimilars. The development and approval of these agents present novel challenges to both pharma and regulatory agencies although there is great promise of high quality, less expensive biologic agents for the treatment of rheumatic diseases. Here, we review the definitions of biosimilars, the regulatory challenges to approval of these agents and the record of approvals of biosimilars to date.

Keywords: biosimilar; biosimilar regulation; intended copy; monoclonal antibody.

Publication types

  • Review

MeSH terms

  • Animals
  • Biosimilar Pharmaceuticals / economics
  • Biosimilar Pharmaceuticals / therapeutic use*
  • Drug Approval / economics
  • Drug Approval / legislation & jurisprudence
  • European Union / economics
  • Humans
  • Patents as Topic / legislation & jurisprudence*
  • Rheumatic Diseases / drug therapy*
  • Rheumatic Diseases / economics
  • Rheumatic Diseases / epidemiology
  • United States / epidemiology


  • Biosimilar Pharmaceuticals