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Biosimilars versus biologics for inflammatory conditions.

作者信息

Perry Danielle, Ton Joey, Kolber Michael R

机构信息

Knowledge Translation Expert with the PEER Group in the Department of Family Medicine at the University of Alberta in Edmonton.

Professor with the PEER Group in the Department of Family Medicine at the University of Alberta in Edmonton.

出版信息

Can Fam Physician. 2019 Sep;65(9):636.

PMID:31515313
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6741793/
Abstract
摘要

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本文引用的文献

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Prescribed Drug Spending in Canada, 2019: A Focus on Public Drug Programs.2019年加拿大的处方药支出：聚焦公共药品计划
Healthc Q. 2020 Apr;23(1):10-12. doi: 10.12927/hcq.2020.26145.
2
Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study.比较 CT-P13 生物类似药与原研英夫利昔单抗治疗活动性克罗恩病患者的疗效和安全性：一项国际、随机、双盲、3 期非劣效性研究。
Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28.
3
Efficacy, safety and immunogenicity of GP2015, an etanercept biosimilar, compared with the reference etanercept in patients with moderate-to-severe rheumatoid arthritis: 24-week results from the comparative phase III, randomised, double-blind EQUIRA study.与参比依那西普相比，GP2015（一种依那西普生物类似药）在中重度类风湿关节炎患者中的疗效、安全性及免疫原性：III期比较性、随机、双盲EQUIRA研究的24周结果
RMD Open. 2018 Nov 14;4(2):e000757. doi: 10.1136/rmdopen-2018-000757. eCollection 2018.
4
Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study.类风湿关节炎患者由参照英夫利昔单抗转换至生物类似药 SB2 与继续使用参照英夫利昔单抗和 SB2 的安全性、免疫原性和疗效：一项随机、双盲、III 期转换研究结果。
Ann Rheum Dis. 2018 Feb;77(2):234-240. doi: 10.1136/annrheumdis-2017-211741. Epub 2017 Oct 17.
5
Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.双盲试验54周后生物类似药SB2与参比英夫利昔单抗的对比：临床、结构及安全性结果
Rheumatology (Oxford). 2017 Oct 1;56(10):1771-1779. doi: 10.1093/rheumatology/kex254.
6
A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis.一项随机、双盲试验，旨在证明GP2013与参比利妥昔单抗联合甲氨蝶呤在活动性类风湿关节炎患者中的生物等效性。
Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.
7
Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.生物类似药ABP 501与阿达木单抗治疗中重度类风湿关节炎患者的疗效和安全性比较：一项随机、双盲、III期等效性研究。
Ann Rheum Dis. 2017 Oct;76(10):1679-1687. doi: 10.1136/annrheumdis-2016-210459. Epub 2017 Jun 5.
8
Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial.从原研英夫利昔单抗转换为生物类似药 CT-P13 与继续使用原研英夫利昔单抗维持治疗（NOR-SWITCH）：一项 52 周、随机、双盲、非劣效性试验。
Lancet. 2017 Jun 10;389(10086):2304-2316. doi: 10.1016/S0140-6736(17)30068-5. Epub 2017 May 11.
9
A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study.一项比较 HD203 联合甲氨蝶呤与依那西普联合甲氨蝶呤在类风湿关节炎患者中的安全性和疗效的 III 期、多中心、随机、双盲、阳性对照、平行分组临床试验：HERA 研究。
Ann Rheum Dis. 2017 Jan;76(1):65-71. doi: 10.1136/annrheumdis-2015-207613. Epub 2016 Feb 23.
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A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.一项随机、双盲、III期研究，比较英夫利昔单抗生物类似药SB2与英夫利昔单抗参比产品类克在接受甲氨蝶呤治疗的中度至重度类风湿性关节炎患者中的疗效。
Ann Rheum Dis. 2017 Jan;76(1):58-64. doi: 10.1136/annrheumdis-2015-207764. Epub 2015 Aug 28.