title: The changing landscape of biosimilars in rheumatology.
abstract: 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.
authors.affiliation: Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin, Berlin, Germany Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Dörner
authors.affiliation: Division Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.affiliation: Comparative Outcomes Group, Bristol, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Cornes
authors.affiliation: Faculty of Pharmacy at University of Lisbon, iMed- Research Institute for Medicines, Portugal.
authors.forename: João
authors.initials: J
authors.lastname: Gonçalves
authors.affiliation: Department of Health Economics, Corvinus University of Budapest, Budapest, Hungary.
authors.forename: László
authors.initials: L
authors.lastname: Gulácsi
authors.affiliation: Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
authors.forename: Jonathan
authors.identifier: 0000-0002-8970-4260
authors.initials: J
authors.lastname: Kay
authors.affiliation: Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.affiliation: Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria Department of Medicine, Hietzing Hospital, Vienna, Austria.
authors.forename: Josef
authors.identifier: 0000-0002-8899-9087
authors.initials: J
authors.lastname: Smolen
authors.affiliation: The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
authors.forename: Yoshiya
authors.initials: Y
authors.lastname: Tanaka
authors.affiliation: Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin, Berlin, Germany.
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Burmester
mesh_terms: D000911:Antibodies, Monoclonal / Q000191:economics / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D060735:Pharmacovigilance; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012219:Rheumatology / Q000639:trends*
chemical_list: D000911:Antibodies, Monoclonal; D059451:Biosimilar Pharmaceuticals
keywords: Anti-TNF; DMARDs (biologic); Economic Evaluations; Rheumatoid Arthritis; Treatment