RT Journal Article
SR Electronic
T1 The role of biosimilars in the treatment of rheumatic diseases
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 322
OP 328
DO 10.1136/annrheumdis-2012-202715
VO 72
IS 3
A1 Thomas Dörner
A1 Vibeke Strand
A1 Gilberto Castañeda-Hernández
A1 Gianfranco Ferraccioli
A1 John D Isaacs
A1 Tore K Kvien
A1 Emilio Martin-Mola
A1 Thomas Mittendorf
A1 Josef S Smolen
A1 Gerd R Burmester
YR 2013
UL http://ard.bmj.com/content/72/3/322.abstract
AB 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.