Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Issue 2 (2nd September 2017)

• Record Type: Journal Article
• Authors: Kay, Jonathan; Schoels, Monika M; Dörner, Thomas; Emery, Paul; Kvien, Tore K; Smolen, Josef S; Breedveld, Ferdinand C
• Other Names: author non-byline.; Bijlsma Johannes Wj author non-byline.; Braun Jürgen author non-byline.; Bykerk Vivian P author non-byline.; Danese Silvio author non-byline.; De wit Maarten Pt author non-byline.; Goncalves João author non-byline.; Huizinga Tom Wj author non-byline.; Isaacs John D author non-byline.; Kavanaugh Arthur F author non-byline.; Kurki Pekka author non-byline.; Luger Thomas A author non-byline.; Müller-ladner Ulf author non-byline.; Pavelka Karel author non-byline.; Schellekens Huub author non-byline.; Strangfeld Anja author non-byline.; Takeuchi Tsutomu author non-byline.; Voshaar Marieke author non-byline.; Weisman Michael H author non-byline.
• Is Part Of: Annals of the rheumatic diseases. Volume 77:Issue 2(2018)
• Page Start: 165
• Page End: 174
• Publication Date: 2017-09-02
• Subjects: Dmards (biologic) -- treatment -- anti-tnf; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2017-211937
• Languages: English
• ISSNs: 0003-4967

Abstract

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.