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The current status for Biosimilars is discussed in two articles, one by Kay et al. providing consensus-based recommendations from EULAR, the other by Cohen et al. providing a comprehensive overview of the approval of five TNF inhibitors and the status of clinical development for additional TNF-inhibitors, as well as rituximab, abatacept and tocilizumab. Importantly, no issues have surfaced based on switching studies in several countries and post-marketing surveillance. Worries about immunogenicity, new safety issues, and loss of efficacy have not materialized. Thus, it is possible that this initial experience and favorable pricing will enable more patients to benefit from these powerful, joint-sparing therapies.
This topic is also discussed in the following three videos:
Kay J, Schoels MM, Dörner T, Emery P, Kvien TK, Smolen JS, Breedveld FC; Task Force on the Use of Biosimilars to Treat Rheumatological DiseasesAnn Rheum Dis. 2017 Sep 2. pii: annrheumdis-2017-211937. doi: 10.1136/annrheumdis-2017-211937
Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology.
Mysler, Pineda, Horiuchi, Singh, Mahgoub, Coindreau, JacobsRheumatology International May 2016, Volume 36, Issue 5, pp 613–625
Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: innovators, biosimilars, and intended copies.
Castañeda-Hernández, Szekanecz, Mysler, Azevedo, Guzman, Gutierrez, Rodríguez, KarateevJoint Bone Spine Volume 81, Issue 6, December 2014, Pages 471–477
Dörner, Strand, Cornes, Gonçalves, Gulácsi , Kay, Kvien, Smolen , Tanaka, Burmester.Annals of the Rheumatic Diseases, 75(6):annrheumdis-2016-209166 · March 2016
Early rheumatoid arthritis treated with tocilizumab, methotrexate, or their combination (U-Act-Early): a multicentre, randomised, double-blind, double-dummy, strategy trialThe Lancet, Volume 388, No. 10042, p343–355, 23 July 2016
Dual Cytokine Inhibition with ABT-122, a Tnf- and IL-17-Targeted Dual Variable Domain Immunoglobulin (DVD-Ig(tm)): Results from a 24-Week Open-Label Extension Study in Patients with Rheumatoid Arthritis [abstract]
Mark C. Genovese1, Michael Weinblatt2, Heikki T. Mansikka3, Paul M. Peloso3, Kun Chen3, Yihan Li3, John Liu3 and Robert J. Padley3Arthritis Rheumatol. 2016; 68 (suppl 10).
Interview with Prof. Iain McInnes at APLAR 2016, ShanghaiSummary With new medicines – and better ways of using them – the last decade has seen a remarkable change...