Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases
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- 2 September 2017
- journal article
- review article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 77 (2), 165-174
- https://doi.org/10.1136/annrheumdis-2017-211937
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.Keywords
This publication has 71 references indexed in Scilit:
- A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS studyAnnals Of The Rheumatic Diseases, 2013
- A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA studyAnnals Of The Rheumatic Diseases, 2013
- Monitoring of adalimumab and antibodies-to-adalimumab levels in patient serum by the homogeneous mobility shift assayJournal of Pharmaceutical and Biomedical Analysis, 2013
- Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritisNature Reviews Rheumatology, 2013
- Comparative Pharmacokinetics of HD203, a Biosimilar of Etanercept, with Marketed Etanercept (Enbrel®)BioDrugs, 2012
- Time‐dependent increased risk for serious infection from continuous use of tumor necrosis factor antagonists over three years in patients with rheumatoid arthritisArthritis Care & Research, 2012
- Developing the Nation's Biosimilars ProgramNew England Journal of Medicine, 2011
- Biosimilars: a regulatory perspective from AmericaArthritis Research & Therapy, 2011
- Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registryAnnals Of The Rheumatic Diseases, 2009
- Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology productsJournal of Pharmaceutical and Biomedical Analysis, 2008