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.

journal_name

Ann Rheum Dis

authors

Dörner T,Strand V,Castañeda-Hernández G,Ferraccioli G,Isaacs JD,Kvien TK,Martin-Mola E,Mittendorf T,Smolen JS,Burmester GR

doi

10.1136/annrheumdis-2012-202715

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

322-8

issue

3

eissn

0003-4967

issn

1468-2060

pii

annrheumdis-2012-202715

journal_volume

72

pub_type

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