title: The role of biosimilars in the treatment of rheumatic diseases.
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.
authors.affiliation: CC12 Department of Medicine, Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Chariteplatz 1, Berlin 10117, Germany. thomas.doerner@charite.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Dörner
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.forename: Gilberto
authors.initials: G
authors.lastname: Castañeda-Hernández
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferraccioli
authors.forename: John D
authors.initials: JD
authors.lastname: Isaacs
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.forename: Emilio
authors.initials: E
authors.lastname: Martin-Mola
authors.forename: Thomas
authors.initials: T
authors.lastname: Mittendorf
authors.forename: Josef S
authors.initials: JS
authors.lastname: Smolen
authors.forename: Gerd R
authors.initials: GR
authors.lastname: Burmester
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000494:pharmacology*; D006801:Humans; D012216:Rheumatic Diseases / Q000188:drug therapy*
chemical_list: D059451:Biosimilar Pharmaceuticals