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Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases
  1. Jonathan Kay1,
  2. Monika M Schoels2,
  3. Thomas Dörner3,
  4. Paul Emery4,
  5. Tore K Kvien5,
  6. Josef S Smolen2,6,
  7. Ferdinand C Breedveld7
  8. on behalf of the Task Force on the Use of Biosimilars to Treat Rheumatological Diseases
  1. 1Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA
  2. 2Department of Internal Medicine, Centre for Rheumatic Diseases, Hietzing Hospital, Vienna, Austria
  3. 3Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany
  4. 4Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, Leeds, UK
  5. 5Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  6. 6Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria
  7. 7Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  1. Correspondence to Professor Jonathan Kay, Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, MA 01605, USA; jonathan.kay{at}umassmemorial.org

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.

  • Dmards (biologic)
  • treatment
  • anti-tnf

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Footnotes

  • Handling editor David S Pisetsky

  • Contributors MMS performed the systematic literature review. JK drafted the manuscript with advice from FCB, TD, PE, TKK and JSS. FCB, TD, PE, JK, TKK and JSS were involved in conceiving the study. All authors were involved in analysing and interpreting data and in producing the recommendations, and all have reviewed and approved the final manuscript.

  • Funding This study was funded by an unrestricted educational grant from Amgen.

  • Competing interests JK has received research grants paid to his institution from AbbVie, Eli Lilly and Company, Genentech, Pfizer and UCB, and has provided expert advice to AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb Company, Crescendo Bioscience, Eli Lilly and Company, Epirus Biopharmaceuticals, Merck Sharp & Dohme, Pfizer, Samsung Bioepis, Sandoz, Roche Laboratories and UCB. TD has received research grants or iDMC honoraria paid to his institution from AbbVie, Ablynx, AstraZeneca, Bristol-Myers Squibb Company, Celgene, GlaxoSmithKline, Samsung Bioepis, Roche Laboratories, Sanofi and UCB, and has provided expert advice to and/or had speaking engagements for AbbVie, Ablynx, Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb Company, Celgene, Epirus Biopharmaceuticals, GlaxoSmithKline, Merck Sharp & Dohme, Pfizer/Hospira, Samsung Bioepis, Roche Laboratories, Sanofi and UCB. PE has received research grants paid to his institution from and has provided expert advice to AbbVie, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme, Novartis, Pfizer, Samsung Bioepis, Sandoz, Roche Laboratories and UCB. TKK has received research grants paid to his institution from AbbVie, Bristol-Myers Squibb Company, Merck Sharp & Dohme, Pfizer/Wyeth, Roche Laboratories and UCB, and has provided expert advice to and/or had speaking engagements for AbbVie, Amgen, Biogen, Bristol-Myers Squibb Company, Celltrion Healthcare, Epirus Biopharmaceuticals, Merck Serono SA, Merck Sharp & Dohme, Mundipharma, Orion, Pfizer/Hospira, Pfizer/Wyeth, Samsung Bioepis, Sandoz, Roche Laboratories and UCB. JSS has received research grants paid to his institution from AbbVie, Eli Lilly and Company, Janssen Biotech, Merck Sharp & Dohme, Pfizer and Roche Laboratories, and has provided expert advice to and/or had speaking engagements for AbbVie, Amgen, AstraZeneca, Astro; Bristol-Myers Squibb Company, Celgene, Celltrion Healthcare, Chugai, Eli Lilly and Company, Gilead, GlaxoSmithKline, ILTOO, Janssen Biotech, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche Laboratories, Samsung Bioepis, Sanofi and UCB. FCB has provided expert advice to and/or had speaking engagements for AbbVie, Amgen, Epirus Biopharmaceuticals, Merck Sharp & Dohme and Pfizer.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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