Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases

on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases

Research output: Contribution to journalArticle

63 Citations (Scopus)

Abstract

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 literature review. Relevant English-language publications through November 2016 were searched systematically for each topic using Medline; selected papers and pertinent reviews were examined for additional relevant references; and abstracts presented at the 2015 and 2016 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) annual scientific meetings were searched for those about biosimilars. The experts used evidence obtained from these studies to develop a set of overarching principles and consensus recommendations. The level of evidence and grade of recommendation were determined for each. By the search strategy, 490 references were identified. Of these, 29 full-text papers were included in the systematic review. Additionally, 20 abstracts were retrieved from the ACR and EULAR conference abstract databases. Five overarching principles and eight consensus recommendations were generated, encompassing considerations regarding clinical trials, immunogenicity, extrapolation of indications, switching between bio-originators and biosimilars and among biosimilars, and cost. The level of evidence and grade of recommendation for each varied according to available published evidence. Five overarching principles and eight consensus recommendations regarding the evaluation and use of biosimilars to treat rheumatological diseases were developed using research-based evidence and expert opinion.

Original languageEnglish
Pages (from-to)165-174
Number of pages10
JournalAnnals of the Rheumatic Diseases
Volume77
Issue number2
DOIs
Publication statusPublished - 2018 Feb 1

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Biosimilar Pharmaceuticals
Consensus
Rheumatology
Gastroenterology
Dermatology
Expert Testimony
Advisory Committees
Rheumatic Diseases
Extrapolation
Publications
Language
Clinical Trials
Databases
Costs and Cost Analysis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases (2018). Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Annals of the Rheumatic Diseases, 77(2), 165-174. https://doi.org/10.1136/annrheumdis-2017-211937

Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. / on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases.

In: Annals of the Rheumatic Diseases, Vol. 77, No. 2, 01.02.2018, p. 165-174.

Research output: Contribution to journalArticle

on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases 2018, 'Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases', Annals of the Rheumatic Diseases, vol. 77, no. 2, pp. 165-174. https://doi.org/10.1136/annrheumdis-2017-211937
on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Annals of the Rheumatic Diseases. 2018 Feb 1;77(2):165-174. https://doi.org/10.1136/annrheumdis-2017-211937
on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases. / Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. In: Annals of the Rheumatic Diseases. 2018 ; Vol. 77, No. 2. pp. 165-174.
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