TY - JOUR
T1 - Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases
AU - on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases
AU - Kay, Jonathan
AU - Schoels, Monika M.
AU - Dörner, Thomas
AU - Emery, Paul
AU - Kvien, Tore K.
AU - Smolen, Josef S.
AU - Breedveld, Ferdinand C.
AU - Bijlsma, Johannes W.J.
AU - Braun, Jürgen
AU - Bykerk, Vivian P.
AU - Danese, Silvio
AU - De Wit, Maarten P.T.
AU - Goncalves, João
AU - Huizinga, Tom W.J.
AU - Isaacs, John D.
AU - Kavanaugh, Arthur F.
AU - Kurki, Pekka
AU - Luger, Thomas A.
AU - Müller-Ladner, Ulf
AU - Pavelkam, Karel
AU - Schellekens, Huub
AU - Strangfeld, Anja
AU - Takeuchi, Tsutomu
AU - Voshaar, Marieke
AU - Weisman, Michael H.
N1 - Funding Information:
This study was funded by an unrestricted educational grant from Amgen.
Publisher Copyright:
© 2018 Article author(s).
PY - 2018/2
Y1 - 2018/2
N2 - 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.
AB - 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.
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U2 - 10.1136/annrheumdis-2017-211937
DO - 10.1136/annrheumdis-2017-211937
M3 - Article
C2 - 28866648
AN - SCOPUS:85041496935
SN - 0003-4967
VL - 77
SP - 165
EP - 174
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 2
ER -