Clinical trial and ‘real-world’ data support switching from a bio-originator to its biosimilar

Published on Jan 18, 2019in Annals of the Rheumatic Diseases14.299
· DOI :10.1136/annrheumdis-2018-214994
Jonathan Kay41
Estimated H-index: 41
(UMMS: University of Massachusetts Medical School),
Thomas Dörner57
Estimated H-index: 57
+ 2 AuthorsFerdinand C. Breedveld61
Estimated H-index: 61
(LUMC: Leiden University Medical Center)
In their correspondence, Cantini and Benucci1 voice concern regarding the recommendation of our international multidisciplinary task force on biosimilars that ‘a single switch from a bio-originator to one of its biosimilars is safe and effective.’2 This recommendation was based on consistent evidence from randomised controlled trials comparing biosimilars to their respective reference products in patients with rheumatologic diseases, in which subjects treated with a reference product were subsequently transitioned to treatment with its biosimilar. In all such studies that have been published to date, there has been no significant loss of efficacy or increase in the incidence of adverse events or of antidrug antibodies following such a change. This has been demonstrated not only for biosimilars of infliximab3–6 and etanercept,7 but also for biosimilars of adalimumab.8 9 The NOR-SWITCH study met its primary endpoint at 52 weeks, thereby demonstrating non-inferiority of changing treatment from bio-originator infliximab to biosimilar infliximab CT-P13 (infliximab-dyyb) to continued treatment with bio-originator infliximab in patients with any of the six inflammatory diseases for which infliximab is indicated who had exhibited stable disease activity over the previous 6 months.10 It is important to recognise that this prospective, double-blind, randomised controlled trial was powered to demonstrate non-inferiority of changing to the biosimilar to continued treatment with the bio-originator in the aggregated population of patients with the six inflammatory diseases; it was not designed to assess non-inferiority of this treatment strategy in any individual disease. As Cantini and Benucci point out, 248 (51.6%) of the 481 subjects enrolled in NOR-SWITCH had inflammatory …
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