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The changing landscape of biosimilars in rheumatology
  1. Thomas Dörner1,2,
  2. Vibeke Strand3,
  3. Paul Cornes4,
  4. João Gonçalves5,
  5. László Gulácsi6,
  6. Jonathan Kay7,
  7. Tore K Kvien8,
  8. Josef Smolen9,10,
  9. Yoshiya Tanaka11,
  10. Gerd R Burmester1
  1. 1Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin, Berlin, Germany
  2. 2Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany
  3. 3Division Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA
  4. 4Comparative Outcomes Group, Bristol, UK
  5. 5Faculty of Pharmacy at University of Lisbon, iMed- Research Institute for Medicines, Portugal
  6. 6Department of Health Economics, Corvinus University of Budapest, Budapest, Hungary
  7. 7Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA
  8. 8Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  9. 9Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria
  10. 10Department of Medicine, Hietzing Hospital, Vienna, Austria
  11. 11The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  1. Correspondence to Professor Thomas Dörner, Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin &DRFZ Berlin, Chariteplatz 01, Berlin 10117, Germany; thomas.doerner{at}


Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities in access to therapy based on economic differences across countries. Since approved biosimilars have already demonstrated highly similar efficacy, it will be most important to establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval.

  • Rheumatoid Arthritis
  • Economic Evaluations
  • DMARDs (biologic)
  • Treatment
  • Anti-TNF

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