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The role of biosimilars in the treatment of rheumatic diseases

Annals of the Rheumatic Diseases, 2013-03, Vol.72 (3), p.322-328 [Peer Reviewed Journal]

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions ;Copyright: 2013 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions ;ISSN: 0003-4967 ;EISSN: 1468-2060 ;DOI: 10.1136/annrheumdis-2012-202715 ;PMID: 23253920 ;CODEN: ARDIAO

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Title:
The role of biosimilars in the treatment of rheumatic diseases
Author: Dörner, Thomas ; Strand, Vibeke ; Castañeda-Hernández, Gilberto ; Ferraccioli, Gianfranco ; Isaacs, John D ; Kvien, Tore K ; Martin-Mola, Emilio ; Mittendorf, Thomas ; Smolen, Josef S ; Burmester, Gerd R
Subjects: Ankylosing Spondylitis ; Anti-TNF ; Biological products ; Biosimilar Pharmaceuticals - pharmacology ; Cost control ; Generic drugs ; Humans ; Manufacturers ; Manufacturing ; Pharmaceutical industry ; Pharmacists ; Physicians ; Regulatory approval ; Rheumatic diseases ; Rheumatic Diseases - drug therapy ; Rheumatoid Arthritis ; Rheumatology
Is Part Of: Annals of the Rheumatic Diseases, 2013-03, Vol.72 (3), p.322-328
Description: 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.
Publisher: England: BMJ Publishing Group Ltd and European League Against Rheumatism
Language: English
Identifier: ISSN: 0003-4967
EISSN: 1468-2060
DOI: 10.1136/annrheumdis-2012-202715
PMID: 23253920
CODEN: ARDIAO
Source: AUTh Library subscriptions: ProQuest Central
MEDLINE
Alma/SFX Local Collection

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The role of biosimilars in the treatment of rheumatic diseases

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