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      The changing landscape of biosimilars in rheumatology

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          Abstract

          Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities in access to therapy based on economic differences across countries. Since approved biosimilars have already demonstrated highly similar efficacy, it will be most important to establish pharmacovigilance databases across countries that are adequate to monitor long-term safety after marketing approval.

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          Most cited references17

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          2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours.

          Chemotherapy-induced neutropenia is a major risk factor for infection-related morbidity and mortality and also a significant dose-limiting toxicity in cancer treatment. Patients developing severe (grade 3/4) or febrile neutropenia (FN) during chemotherapy frequently receive dose reductions and/or delays to their chemotherapy. This may impact the success of treatment, particularly when treatment intent is either curative or to prolong survival. In Europe, prophylactic treatment with granulocyte-colony stimulating factors (G-CSFs), such as filgrastim (including approved biosimilars), lenograstim or pegfilgrastim is available to reduce the risk of chemotherapy-induced neutropenia. However, the use of G-CSF prophylactic treatment varies widely in clinical practice, both in the timing of therapy and in the patients to whom it is offered. The need for generally applicable, European-focused guidelines led to the formation of a European Guidelines Working Party by the European Organisation for Research and Treatment of Cancer (EORTC) and the publication in 2006 of guidelines for the use of G-CSF in adult cancer patients at risk of chemotherapy-induced FN. A new systematic literature review has been undertaken to ensure that recommendations are current and provide guidance on clinical practice in Europe. We recommend that patient-related adverse risk factors, such as elderly age (≥65 years) and neutrophil count be evaluated in the overall assessment of FN risk before administering each cycle of chemotherapy. It is important that after a previous episode of FN, patients receive prophylactic administration of G-CSF in subsequent cycles. We provide an expanded list of common chemotherapy regimens considered to have a high (≥20%) or intermediate (10-20%) risk of FN. Prophylactic G-CSF continues to be recommended in patients receiving a chemotherapy regimen with high risk of FN. When using a chemotherapy regimen associated with FN in 10-20% of patients, particular attention should be given to patient-related risk factors that may increase the overall risk of FN. In situations where dose-dense or dose-intense chemotherapy strategies have survival benefits, prophylactic G-CSF support is recommended. Similarly, if reductions in chemotherapy dose intensity or density are known to be associated with a poor prognosis, primary G-CSF prophylaxis may be used to maintain chemotherapy. Clinical evidence shows that filgrastim, lenograstim and pegfilgrastim have clinical efficacy and we recommend the use of any of these agents to prevent FN and FN-related complications where indicated. Filgrastim biosimilars are also approved for use in Europe. While other forms of G-CSF, including biosimilars, are administered by a course of daily injections, pegfilgrastim allows once-per-cycle administration. Choice of formulation remains a matter for individual clinical judgement. Evidence from multiple low level studies derived from audit data and clinical practice suggests that some patients receive suboptimal daily G-CSFs; the use of pegfilgrastim may avoid this problem. Copyright © 2010 Elsevier Ltd. All rights reserved.
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            If nothing goes wrong, is everything all right? Interpreting zero numerators.

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              Incorporating considerations of resources use into grading recommendations.

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                Author and article information

                Journal
                Ann Rheum Dis
                Ann. Rheum. Dis
                annrheumdis
                ard
                Annals of the Rheumatic Diseases
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0003-4967
                1468-2060
                June 2016
                8 March 2016
                : 75
                : 6
                : 974-982
                Affiliations
                [1 ]Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin , Berlin, Germany
                [2 ]Deutsches Rheumaforschungszentrum (DRFZ) , Berlin, Germany
                [3 ]Division Immunology/Rheumatology, Stanford University School of Medicine , Palo Alto, California, USA
                [4 ]Comparative Outcomes Group, Bristol, UK
                [5 ]Faculty of Pharmacy at University of Lisbon, iMed- Research Institute for Medicines , Portugal
                [6 ]Department of Health Economics, Corvinus University of Budapest , Budapest, Hungary
                [7 ]Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center , Worcester, Massachusetts, USA
                [8 ]Department of Rheumatology, Diakonhjemmet Hospital , Oslo, Norway
                [9 ]Division of Rheumatology, Department of Medicine 3, Medical University of Vienna , Vienna, Austria
                [10 ]Department of Medicine, Hietzing Hospital , Vienna, Austria
                [11 ]The First Department of Internal Medicine, School of Medicine , University of Occupational and Environmental Health , Kitakyushu, Japan
                Author notes

                Handling editor Hans WJ Bijlsma

                [Correspondence to ] Professor Thomas Dörner, Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin &DRFZ Berlin, Chariteplatz 01, Berlin 10117, Germany; thomas.doerner@ 123456charite.de

                TD and VS shared first authorship.

                Author information
                http://orcid.org/0000-0002-8970-4260
                http://orcid.org/0000-0002-8899-9087
                Article
                annrheumdis-2016-209166
                10.1136/annrheumdis-2016-209166
                4893105
                26964144
                b1b06ba3-6fec-4025-8812-84c426c68f93
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 11 January 2016
                : 17 February 2016
                : 18 February 2016
                Funding
                Funded by: F. Hoffman-La Roche, http://dx.doi.org/10.13039/100007013;
                Categories
                1506
                Review
                Custom metadata
                unlocked

                Immunology
                rheumatoid arthritis,economic evaluations,dmards (biologic),treatment,anti-tnf
                Immunology
                rheumatoid arthritis, economic evaluations, dmards (biologic), treatment, anti-tnf

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