Biosimilars in IBD: from theory to practice

被引:72
作者
Danese, Silvio [1 ,2 ]
Bonovas, Stefanos [2 ]
Peyrin-Biroulet, Laurent [3 ,4 ]
机构
[1] Humanitas Univ, Dept Biomed Sci, Via Manzoni 113, I-20089 Milan, Italy
[2] IBD Ctr, Dept Gastroenterol, Humanitas Clin & Res Ctr, Via Manzoni 56, I-20089 Milan, Italy
[3] Lorraine Univ, Univ Hosp Nancy, Dept Hepatogastroenterol, Vandoeuvre Les Nancy, France
[4] Lorraine Univ, Univ Hosp Nancy, INSERM, U954, Vandoeuvre Les Nancy, France
关键词
INFLAMMATORY-BOWEL-DISEASE; ACTIVE RHEUMATOID-ARTHRITIS; ULCERATIVE-COLITIS; CROHNS-DISEASE; PARALLEL-GROUP; ANKYLOSING-SPONDYLITIS; NETWORK METAANALYSIS; INNOVATOR INFLIXIMAB; POSITION STATEMENT; EUROPEAN-UNION;
D O I
10.1038/nrgastro.2016.155
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Biologic agents have revolutionized the care management of many life-threatening and debilitating diseases. As patents for older biologic therapies have begun to expire, the market has opened to copy versions of the originators-commonly referred to as biosimilars, follow-on biologic agents or subsequent-entry biologic agents-which are expected to gain a portion of the market, reduce health-care spending and increase treatment access worldwide. Importantly for patients with IBD, CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the European Medicines Agency in September 2013 and by the FDA in April 2016. In May 2016, SB2 was the second biosimilar to infliximab receiving marketing authorization in Europe. Currently, >20 other biosimilars to infliximab and adalimumab are in the development pipeline. Their similar but-not-identical nature, and the concept of extrapolating efficacy and safety data from one therapeutic indication to another, seem to be confusing to physicians and cause concerns about the efficacy and safety of biosimilar products. A relevant debate is still ongoing in the field of IBD. This Review discusses the scientific principles underlying the biosimilar concept established in Europe and the USA, and discusses the current state of knowledge on biosimilar use in IBD.
引用
收藏
页码:22 / 31
页数:10
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