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Are There Benefits and Risks to Biosimilars from a Patient Perspective

Published on Aug 1, 2019in Rheumatic Diseases Clinics of North America3.527
· DOI :10.1016/j.rdc.2019.04.001
Jonathan Kay45
Estimated H-index: 45
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Abstract
: Biosimilars are copies of biologic medications, which no longer are protected by patent, that are intended to be marketed at lower prices than their reference products to increase patient access to treatment. Because a biosimilar must have equivalent pharmacokinetic parameters and efficacy and comparable safety and immunogenicity with its reference product, the only significant difference between the two should be cost. Lower-priced biosimilars are intended to introduce market competition. The availability of biosimilars should yield savings for the health care system and improve treatment outcomes by expanding patient access to effective medications. However, patients should partake of these cost savings.
  • References (23)
  • Citations (0)
References23
Newest
#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
#1Andrew BlauveltH-Index: 48
#2Jean-Philippe Lacour (University of Nice Sophia Antipolis)H-Index: 36
Last. Craig L. LeonardiH-Index: 50
view all 9 authors...
BACKGROUND: Adalimumab is used to treat several inflammatory diseases, including plaque psoriasis. GP2017 is a proposed adalimumab biosimilar. OBJECTIVES: To assess the impact of multiple switches between GP2017 and reference adalimumab (ref-ADMB) following the demonstration of equivalent efficacy and similar safety and immunogenicity, in adult patients with active, clinically stable, moderate-to-severe plaque psoriasis. METHODS: This 51-week double-blinded, phase III study randomly assigned pat...
24 CitationsSource
Immunogenicity is an important aspect of all biologics. Switching between biological products has triggered intensive discussion on the interchangeability of a biosimilar with its reference medicine, with the main focus being immunogenicity and different perspectives within Europe1 and the United States.2 Given that immunogenicity assay validation and performance characteristics differ from assay to assay, the immunogenicity assay parameters discussed here enable the interpretation of the immuno...
3 CitationsSource
#1Stanley CohenH-Index: 29
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
Background EGALITY was a phase III confirmatory efficacy and safety study conducted in patients with plaque-type psoriasis as a part of totality of evidence gathered during the development of GP2015, an etanercept biosimilar. Objective To demonstrate equivalent efficacy and comparable safety and immunogenicity of GP2015 and the etanercept originator product (ETN, Enbrel®), and evaluate effects of repeated switching between GP2015 and ETN. Results for efficacy, safety and immunogenicity during tr...
24 CitationsSource
#1S L Bridges (UAB: University of Alabama at Birmingham)H-Index: 35
#2Douglas W. White (Gundersen Health System)H-Index: 15
Last. Stanley CohenH-Index: 29
view all 8 authors...
8 CitationsSource
#1Josef S. Smolen (Medical University of Vienna)H-Index: 115
#2Jung-Yoon Choe (DCU: Catholic University of Daegu)H-Index: 20
Last. Young Hee Rho (Samsung)H-Index: 30
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: 45
#2Monika SchoelsH-Index: 17
Last. Ferdinand C. Breedveld (LUMC: Leiden University Medical Center)H-Index: 59
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
#1L. TweehuysenH-Index: 8
#2Bart J. F. van den Bemt (Radboud University Nijmegen)H-Index: 19
Last. A.A. den Broeder (Radboud University Nijmegen)H-Index: 34
view all 7 authors...
Objective To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity and safety after transitioning treatment from originator infliximab (Remicade®, REM) to biosimilar infliximab (CT-P13) in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis in daily practice. Methods 192 of 222 REM-treated patients agreed to transition to CT-P13 and were included in this multicenter prospective cohort study. Change in DAS28-CRP, BASDAI, CRP and (anti-) infliximab l...
45 CitationsSource
#1Bente GlintborgH-Index: 13
#2Inge Juul Sørensen (UCPH: University of Copenhagen)H-Index: 14
Last. Merete Lund Hetland (UCPH: University of Copenhagen)H-Index: 45
view all 24 authors...
Objectives According to guidelines, a nationwide non-medical switch from originator (INX, Remicade) to biosimilar infliximab (Remsima, CT-P13) was conducted in Danish patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA). We investigated disease activity before/after switching and retention rates in the DANBIO registry. Methods Disease activities 3 months before and after switch and changes over time were calculated. Flare was defined as change in...
85 CitationsSource
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Newest
#1Frank I. Scott (Anschutz Medical Campus)H-Index: 14
#2Michelle Luo (UPenn: University of Pennsylvania)
Last. James D. Lewis (Takeda Pharmaceutical Company)H-Index: 79
view all 9 authors...
BACKGROUND AND AIMS: There are limited data on the most cost-effective sequencing of biologics for ulcerative colitis (UC). METHODS: We utilized Markov modelling to identify the most cost-effective position for vedolizumab among biologics for steroid-dependent UC with a base-case of a 35-year-old male. We assessed three treatment algorithms, with vedolizumab use prior to an initial anti-tumor necrosis factor alpha (anti-TNF) and azathioprine (Algorithm 1), prior to a second anti-TNF and azathiop...
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