Article Text

Download PDFPDF

Biosimilars in rheumatology: what the clinician should know
  1. Gilberto Castañeda-Hernández1,2,
  2. Rodrigo González-Ramírez1,
  3. Jonathan Kay3 and
  4. Morton A Scheinberg4,5
  1. 1Departamento de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, México, Distrito Federal, Mexico
  2. 2Centro Latino Americano de Pesquisa em Biológicos, Rio de Janeiro, Brazil
  3. 3Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA
  4. 4Hospital AACD, São Paulo, São Paulo, Brazil
  5. 5Hospital Israelita Albert Einstein, São Paulo, São Paulo, Brazil
  1. Correspondence to Dr Gilberto Castañeda-Hernández; gcastane{at}


Biosimilars are now a reality in rheumatology. Although analytical and non-clinical procedures to establish similarity have evolved significantly, clinical trials demonstrating equivalent efficacy and safety are absolutely required for all biosimilars. The design of such trials, including equivalence and non-inferiority statistical approaches, are discussed. Clinical evidence on biosimilars that have been approved recently or are presently being developed for use in rheumatology is also reviewed and contrasted with that available for biomimics (or intended copies), which are non-innovator biologics that are marketed in several countries but have not undergone review according to a regulatory pathway for biosimilars.

  • Outcomes research
  • Pharmacokinetics
  • Anti-TNF

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.