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Overcoming barriers to biosimilars in inflammatory arthritis.

Published on Feb 1, 2020in Nature Reviews Rheumatology18.545
· DOI :10.1038/S41584-019-0359-7
Jonathan Kay45
Estimated H-index: 45
(UMMS: University of Massachusetts Medical School)
Abstract
The availability of biosimilars to treat inflammatory diseases has generated concern about changing patients from a bio-originator to its biosimilar to save costs. Studies published in 2019 support the effectiveness and safety of ‘nonmedical switching’ and highlight the benefits of communicating information about biosimilars to patients in a positive light.
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References6
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#1Chiara Gasteiger (University of Auckland)H-Index: 2
#2Annie S. K. Jones (University of Auckland)H-Index: 4
Last. Keith J. Petrie (University of Auckland)H-Index: 56
view all 7 authors...
OBJECTIVE: Patients may hold negative perceptions towards biosimilars which can create barriers to their uptake. Physicians also report uncertainty in how best to explain biosimilars. The aim of this study was to measure the effect of differently framed explanations on patients' perceptions of and willingness to change to a biosimilar in a hypothetical drug switch. METHODS: Ninety-six patients with rheumatic diseases taking an originator biologic were randomised to receive one of four biosimilar...
4 CitationsSource
#1G. L. GollH-Index: 9
#2K.K. Jørgensen (Ahus: Akershus University Hospital)H-Index: 12
Last. Tore K. KvienH-Index: 91
view all 48 authors...
BACKGROUND AND OBJECTIVES: The 52-week, randomized, double-blind, noninferiority, government-funded NOR-SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT-P13 was not inferior to continued treatment with infliximab originator. The NOR-SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT-P13 throughout the 78-week study period (maintenance group) versus patients switched to CT-P13 at week 52 (switch group). T...
11 CitationsSource
#1Bente Glintborg (Gentofte Hospital)H-Index: 13
#2Anne Loft (AU: Aarhus University)H-Index: 39
Last. Merete Lund Hetland (UCPH: University of Copenhagen)H-Index: 45
view all 24 authors...
Objectives Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retentio...
23 CitationsSource
#1L. TweehuysenH-Index: 8
Last. A.A. den Broeder (Radboud University Nijmegen)H-Index: 34
view all 8 authors...
OBJECTIVE: To evaluate the effects of non-mandatory transitioning from the originator biologic drug etanercept (ETN) to its biosimilar, SB4, on drug survival and effectiveness in a controlled cohort study of patients with an inflammatory rheumatic disease. METHODS: In 2016, 642 patients were asked to transition their treatment from originator ETN to biosimilar SB4 by a structured communication strategy with opt-out option. Patients who consented to switch to SB4 were considered eligible for incl...
22 CitationsSource
#1K.K. Jørgensen (Ahus: Akershus University Hospital)H-Index: 12
#2Inge C. OlsenH-Index: 17
Last. Camilla C ZettelH-Index: 1
view all 57 authors...
Summary Background TNF inhibitors have improved treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, but are expensive therapies. The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy, safety, and immunogenicity. Methods The study is a randomised, non-inferiority, double-blind, phase 4 trial with 52 weeks of follow-up. Adult patie...
262 CitationsSource
The increasing use of biosimilars in the context of rheumatic diseases has been met with several challenges unique to this type of drugs. In this Review, Dorner and Kay describe the fast adoption of biosimilar agents worldwide, highlighting the different approaches to regulation implemented by national and supranational health care policy-makers. Issues such as extrapolation of indications and the definition of strategies for adequate postmarketing pharmacovigilance are also discussed.
57 CitationsSource
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