Biosimilars in rheumatology: A review of the evidence and their place in the treatment algorithm.
Biosimilars in rheumatology: A review of the evidence and their place in the treatment algorithm.
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DOI：
10.1093/rheumatology/kex277
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发表时间：
2017-08-01
期刊：
影响因子：
--
通讯作者：
Skapenko A
中科院分区：
文献类型：
--
作者：
Schulze-Koops H;Skapenko A
确定生物相似性涉及一项全面的工作，重点是确定生物仿制药和参考产品的分子特征和临床前概况的可比性，这样就不需要进行广泛的临床测试来确保临床结果的可比性。欧盟批准了三种抗 TNF 生物仿制药用于风湿性疾病患者。英夫利昔单抗 (Remicade®) 生物仿制药 CT-P13（Remsima® 和 Inflectra®）和 SB2 (Flixabi®) 以及依那西普 (Enbrel®) 生物仿制药 SB4 (Benepali®) 经过广泛评估，已显示出与其参考药品的密切可比性。风湿病治疗指南承认，生物仿制药和生物 DMARD (bDMARD) 在临床实践中可以互换，除非患者对参考药物缺乏疗效或耐受性。鉴于成本是有效使用 bDMARD 的障碍，引入成本较低的生物仿制药可能会扩大可及性并消除治疗不平等。面对处方决定的医生应该对确保生物仿制药与其参考药物的可比性的稳健而详尽的流程感到放心。从头开始使用生物仿制药，并在不同的参考生物制剂缺乏疗效或耐受性后改用生物仿制药可能是最容易采用的策略，但考虑到潜在的成本影响，也应考虑在成功治疗期间进行转换。生物仿制药 bDMARD 的引入有可能改善患者获得有效生物治疗的机会，更好地适应医疗保健预算的限制并改善患者的总体治疗结果。
Determining biosimilarity involves a comprehensive exercise with a focus on determining the comparability of the molecular characteristics and preclinical profile of the biosimilar and reference product, such that there is less need for extensive clinical testing to assure comparability of clinical outcomes. Three anti-TNF biosimilar agents are approved for patients with rheumatic diseases in the European Union. The infliximab (Remicade®) biosimilars CT-P13 (Remsima® and Inflectra®) and SB2 (Flixabi®) and the etanercept (Enbrel®) biosimilar SB4 (Benepali®) have shown close comparability to their reference medicinal products, having undergone extensive evaluations. Guidelines on the treatment of rheumatic diseases have acknowledged that biosimilars and biologic DMARDs (bDMARDs) are interchangeable in clinical practice, except when patients experience lack of efficacy or tolerability with the reference agent. Given that cost is a barrier to effective bDMARD use, the introduction of less costly biosimilars is likely to widen access and dissipate treatment inequalities. Physicians faced with prescribing decisions should be reassured by the robust and exhaustive process that is involved in assuring comparability of biosimilars with their reference agents. De novo usage of a biosimilar and switching to a biosimilar following lack of efficacy or tolerability with a different reference biologic agent are likely to be strategies most easily adopted, although switching during successful treatment should also be considered given the potential cost implications. The introduction of biosimilar bDMARDs has the potential to improve patient access to effective biologic therapy, to better accommodate restraints within healthcare budgets and to improve overall patient outcomes.
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影响因子：
27.4
作者：
Dörner T;Strand V;Cornes P;Gonçalves J;Gulácsi L;Kay J;Kvien TK;Smolen J;Tanaka Y;Burmester GR
通讯作者：
Burmester GR
影响因子：
4.6
作者：
Hofmann, Hans-Peter;Kronthaler, Ulrich;Da Silva, Antonio
通讯作者：
Da Silva, Antonio
影响因子：
5.3
作者：
Jung SK;Lee KH;Jeon JW;Lee JW;Kwon BO;Kim YJ;Bae JS;Kim DI;Lee SY;Chang SJ
通讯作者：
Chang SJ
影响因子：
--
作者：
Goekoop-Ruiterman, YPM;de Vries-Bouwstra, JK;Dijkmans, C
通讯作者：
Dijkmans, C
影响因子：
10.3
作者：
Griffiths, C. E. M.;Thaci, D.;Afonso, M.
通讯作者：
Afonso, M.