Biosimilars antibodies: positioning compared to originators-the experience in rheumatology and the biosimilars of trastuzumab in oncology

被引：0
|
作者：
Pivot, Xavier [1 ]
Goupille, Philippe [2 ,3 ]
机构：
[1] Inst Cancerol Strasbourg, Ctr Paul Strauss, Strasbourg, France
[2] Univ Tours, EA 7501, GICC, Tours, France
[3] CHRU Tours, Serv Rhumatol, Tours, France
来源：
M S-MEDECINE SCIENCES | 2020年 / 35卷 / 12期
关键词：
RANDOMIZED PHASE-I; BREAST-CANCER; DOUBLE-BLIND; PHARMACOKINETICS; SAFETY; INFLIXIMAB; SWITCH; IMMUNOGENICITY; BIOEQUIVALENCE; EQUIVALENCE;
D O I：
10.1051/medsci/2019214
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
Biosimilars have demonstrated their equivalence with biologic originators, according to rigorous specifications imposed by the regulatory agencies, the FDA and the EMA. Their development is justified by the very high cost of biopharmaceuticals, and strong incentives for their prescription lead us to hope substantial savings, allowing to finance other innovative molecules. Trastuzumab marked history of the treatment of breast cancer. Four biosimilars of trastuzumab are available for routine use and we will detail the key points of their development.
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收藏
页码：1137 / 1145
页数：9
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