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Review
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}cinvestav.mx

Abstract

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.

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  • Received November 28, 2014.
  • Revision received April 20, 2015.
  • Accepted April 21, 2015.
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