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.
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.
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.
Vet Pathol. 2015 Mar;52(2):419-26. doi: 10.1177/0300985814547282. Epub 2014 Aug 26.
4
The economics of biosimilars.
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.
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.
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.
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.
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