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围绕生物类似药问世的生物医学与市场问题。

Biomedical and Market Issues Surrounding the Advent of Biosimilars.

作者信息

Cline Abigail, Turrentine Jake E

机构信息

Medical College of Georgia, Augusta University, 1120 15th Street, Augusta, GA, 30912, USA.

Division of Dermatology, Department of Medicine, Augusta University, Augusta, GA, USA.

出版信息

Dermatol Ther (Heidelb). 2016 Sep;6(3):341-5. doi: 10.1007/s13555-016-0127-4. Epub 2016 Jun 21.

DOI:10.1007/s13555-016-0127-4
PMID:27329376
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4972733/
Abstract

As the patents associated with the biologics are set to expire in the near future, a new type of therapy appears on the horizon, and it is quite similar to the biologics. This commentary examines the biomedical and market issues surrounding the advent of biosimilars.

摘要

由于与生物制剂相关的专利在不久的将来即将到期,一种新型疗法即将出现,且它与生物制剂颇为相似。本评论探讨了围绕生物类似药出现的生物医学和市场问题。

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本文引用的文献

1
Generic prices take flight: the FDA is struggling to ground them.仿制药价格飙升:美国食品药品监督管理局正努力加以控制。
P T. 2014 Dec;39(12):833-45.
2
First experience with therapy of severe forms of psoriasis with biosimilar infliximab.
J Eur Acad Dermatol Venereol. 2016 Mar;30(3):491-3. doi: 10.1111/jdv.12876. Epub 2014 Nov 21.
3
Frontiers in nonclinical drug development: biosimilars.非临床药物研发前沿:生物类似药
Vet Pathol. 2015 Mar;52(2):419-26. doi: 10.1177/0300985814547282. Epub 2014 Aug 26.
4
The economics of biosimilars.生物类似药的经济学
Am Health Drug Benefits. 2013 Sep;6(8):469-78.
5
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 study.一项旨在证明 CT-P13 与创新型英夫利昔单抗联合甲氨蝶呤治疗活动性类风湿关节炎患者时在疗效和安全性方面等效的随机、双盲、平行分组研究:PLANETRA 研究。
Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16.
6
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 study.一项比较 CT-P13 和创新型英夫利昔单抗在强直性脊柱炎患者中的药代动力学、安全性和疗效的随机、双盲、多中心、平行组、前瞻性研究:PLANETAS 研究。
Ann Rheum Dis. 2013 Oct;72(10):1605-12. doi: 10.1136/annrheumdis-2012-203091. Epub 2013 May 16.
7
Biopharmaceuticals and biosimilars in psoriasis: what the dermatologist needs to know.银屑病的生物制药和生物类似药:皮肤科医生需要了解的知识。
J Am Acad Dermatol. 2012 Feb;66(2):317-22. doi: 10.1016/j.jaad.2011.08.034.
8
Cost-effectiveness of moderate-to-severe psoriasis treatment.
Expert Opin Pharmacother. 2006 Feb;7(2):157-67. doi: 10.1517/14656566.7.2.157.