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The role of biosimilars in the treatment of rheumatic diseases
  1. Thomas Dörner1,2,
  2. Vibeke Strand3,
  3. Gilberto Castañeda-Hernández4,
  4. Gianfranco Ferraccioli5,
  5. John D Isaacs6,7,
  6. Tore K Kvien8,
  7. Emilio Martin-Mola9,
  8. Thomas Mittendorf10,
  9. Josef S Smolen11,
  10. Gerd R Burmester1
  1. 1CC12 Department of Medicine, Rheumatology and Clinical Immunology, Charité—University Medicine Berlin, Berlin, Germany
  2. 2Deutsches Rheumaforschungszentrum (DRFZ), Charité—University Medicine Berlin, Berlin, Germany
  3. 3Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA
  4. 4Department of Pharmacology, Cinvestav, Mexico-City, Mexico
  5. 5Rheumatology Division, Catholic University of the Sacred Heart, Rome, Italy
  6. 6Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK
  7. 7Musculoskeletal Directorate, Newcastle upon Tyne hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
  8. 8Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  9. 9Rheumatology Unit, La Paz University Hospital, Madrid, Spain
  10. 10Herescon GmbH, Hannover, Germany
  11. 11Department of Medicine III, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
  1. Correspondence to Professor Thomas Dörner, CC12 Department of Medicine, Rheumatology and Clinical Immunology, Charité—University Medicine Berlin, Chariteplatz 1, Berlin 10117 , Germany; thomas.doerner{at}charite.de

Abstract

The first biological therapeutics in rheumatology are approaching patent expiration, encouraging development of ‘follow-on’ versions, known as ‘biosimilars’. Biological agents range from simple replacement hormones to complex monoclonal antibodies and soluble receptors: large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate. Post-translational modifications, such as glycosylation, may occur from changes in cell lines and/or manufacturing processes, resulting in products that are highly similar, but not identical, to approved ‘reference’ agents, hence, the term ‘biosimilar’, rather than ‘bioidentical’. Even minor modifications in manufacturing processes, which iteratively occur with reference products due to improvements in efficiency, scale up to meet commercial demands or changes in manufacturing sites, may alter biological function and/or immunogenicity, potentially changing their safety and efficacy profile. As biosimilars are now in randomised controlled trials for treatment of rheumatic diseases, rheumatologists face decisions regarding equipoise and will need to consider their clinical use versus reference products. A clear understanding of the inherent differences between reference antibodies and biosimilars, their clinical implications and the processes governing regulation, approval and clinical use of biosimilars, is paramount. A panel of international experts in the field of rheumatology recently convened to evaluate and discuss these issues.

  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Anti-TNF

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