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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
(Charité)
+ 2 AuthorsFerdinand C. Breedveld61
Estimated H-index: 61
(LUMC: Leiden University Medical Center)
Sources
Abstract
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 …
  • References (21)
  • Citations (2)
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References21
Newest
#1Vincent Germain (University of Bordeaux)H-Index: 2
#2Marc ScherlingerH-Index: 6
Last. Thierry Schaeverbeke (University of Bordeaux)H-Index: 12
view all 4 authors...
To date, all available data regarding the switch from bio-originator to its biosimilar are reassuring, and the switch has been recommended as a shared patient–physician decision in recent consensus-based recommendations.1 In particular, the Norway's infliximab switching study (NOR-SWITCH study), a 52-week randomised double-blind trial, strongly supports the efficacy and safety of the switch from originator infliximab (OI) to its biosimilar CT-P13 in patients with a stable disease.2 However, long...
2 CitationsSource
We read with interest the recently published recommendations for the use of biosimilars in rheumatology practice.1 However, we have some concerns regarding recommendation 6 on the efficacy and safety of switching from the originator biologic to the respective biosimilar. Considering the strong impact of the European League Against Rheumatism recommendations on real-life clinical decisions, such recommendation seems not sufficiently supported by the evidence because available data do not allow to...
13 CitationsSource
#1Bente Glintborg (Gentofte Hospital)H-Index: 12
#2Anne Loft (AU: Aarhus University)H-Index: 32
Last. Merete Lund Hetland (UCPH: University of Copenhagen)H-Index: 44
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
#1Michael E. Weinblatt (Brigham and Women's Hospital)H-Index: 78
#2Asta Baranauskaite (Lithuanian University of Health Sciences)H-Index: 14
Last. Jeehoon Ghil (Samsung)H-Index: 9
view all 10 authors...
The 24-week equivalent efficacy and comparable safety results of the biosimilar SB5 and reference adalimumab (ADA) from the phase III randomized study in patients with moderate-to-severe rheumatoid arthritis (RA) have been reported previously. We undertook this transition study to evaluate patients who switched from ADA to SB5 or who continued to receive SB5 or ADA up to 52 weeks.In this phase III study, patients were initially randomized 1:1 to receive SB5 or ADA (40 mg subcutaneously every oth...
23 CitationsSource
#1Stanley CohenH-Index: 23
Last. Deepak Assudani (Boehringer Ingelheim)H-Index: 3
view all 7 authors...
Objective To demonstrate clinical equivalence of adalimumab biosimilar candidate BI 695501 with Humira. Methods Patients with active rheumatoid arthritis on stable methotrexate were randomised to BI 695501 or Humira in a double-blind, parallel-group, equivalence study. At week 24, patients were rerandomised to continue BI 695501 or Humira, or switch from Humira to BI 695501. The coprimary endpoints were the percentage of patients achieving the American College of Rheumatology 20% response criter...
23 CitationsSource
#1Josef S. Smolen (Medical University of Vienna)H-Index: 114
#2Jung-Yoon Choe (DCU: Catholic University of Daegu)H-Index: 19
Last. Young Hee Rho (Samsung)H-Index: 28
view all 15 authors...
Objectives Efficacy, safety and immunogenicity results from the phase III study of SB2, a biosimilar of reference infliximab (INF), were previously reported through 54 weeks. This transition period compared results in patients with rheumatoid arthritis (RA) who switched from INF to SB2 with those in patients who maintained treatment with INF or SB2. Methods Patients with moderate to severe RA despite methotrexate treatment were randomised (1:1) to receive SB2 or INF at weeks 0, 2 and 6 and every...
28 CitationsSource
#1Jonathan Kay (UMMS: University of Massachusetts Medical School)H-Index: 41
#2Monika SchoelsH-Index: 19
Last. Ferdinand C. Breedveld (LUMC: Leiden University Medical Center)H-Index: 61
view all 7 authors...
The study aimed to develop evidence-based recommendations regarding the evaluation and use of biosimilars to treat rheumatological diseases. The task force comprised an expert group of specialists in rheumatology, dermatology and gastroenterology, and pharmacologists, patients and a regulator from ten countries. Four key topics regarding biosimilars were identified through a process of discussion and consensus. Using a Delphi process, specific questions were then formulated to guide a systematic...
58 CitationsSource
#1Paul EmeryH-Index: 143
#2Jiri VencovskyH-Index: 38
Last. Jeehoon Ghil (Samsung)H-Index: 9
view all 10 authors...
Objectives SB4 (Benepali, Brenzys) is a biosimilar of reference etanercept (ETN). In a randomised, double-blind, 52-week study, SB4 demonstrated comparable efficacy and safety to ETN in patients with rheumatoid arthritis (RA). The open-label extension period evaluated long-term efficacy, safety and immunogenicity when continuing SB4 versus switching from ETN to SB4. Methods In the randomised, double-blind phase, patients received weekly subcutaneous administration of 50 mg SB4 or ETN with backgr...
33 CitationsSource
#1Jérôme Avouac (Paris V: Paris Descartes University)H-Index: 44
#2Anna Moltó (Paris V: Paris Descartes University)H-Index: 15
Last. Maxime Dougados (Paris V: Paris Descartes University)H-Index: 128
view all 20 authors...
Abstract Objective To investigate effectiveness of systematic switching treatment from innovator infliximab to biosimilar infliximab, and its associated factors. Methods In this prospective observational study, all adult patients receiving maintenance therapy with innovator infliximab in Cochin University Hospital were systematically switched to biosimilar infliximab. Effectiveness was assessed by the retention rate of biosimilar infliximab at the time of the third infusion. Sensitivity analyses...
16 CitationsSource
Objective CT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment.
7 CitationsSource
Cited By2
Newest
#1Ulf Lindström (University of Gothenburg)H-Index: 5
#2Bente GlintborgH-Index: 12
Last. Lennart T. H. Jacobsson (University of Gothenburg)H-Index: 39
view all 12 authors...
Objective Although clinical trials support equivalence of originator products and biosimilars for etanercept and infliximab, real-world studies among biologics-naive patients with spondyloarthritis (SpA) are lacking. The objectives were to compare treatment retention in biologics-naive patients with SpA starting either the originator product or a biosimilar of infliximab and etanercept, and to explore the baseline characteristics of these patients. Methods Patients with SpA (ankylosing spondylit...
Source
#1Bente GlintborgH-Index: 12
#2Rikke Ibsen (iMinds)H-Index: 14
Last. Jakob KjellbergH-Index: 18
view all 5 authors...
Objectives In year 2016, Danish national guidelines included a mandatory switch of patients with inflammatory rheumatic diseases treated with originator etanercept (ETA) to biosimilar SB4 in routine care. We aimed to explore if switching lead to increased healthcare utilisation and costs. Methods Observational cohort study. Adult patients who switched from ETA to SB4 were identified in the Danish nationwide DANBIO registry. In the National Patient Registry, we identified health utilisation (hosp...
2 CitationsSource