Interchangeability, immunogenicity and biosimilars

被引:84
作者
Ebbers, Hans C. [1 ]
Crow, Stacy A. [2 ]
Vulto, Arnold G. [2 ]
Schellekens, Huub [3 ,4 ]
机构
[1] Univ Utrecht, UIPS, Div Pharmacoepidemiol & Clin Pharmacol, Utrecht, Netherlands
[2] Erasmus Univ, Dept Hosp Pharm, Med Ctr, Rotterdam, Netherlands
[3] Univ Utrecht, Copernicus Inst, Dept Innovat & Environm Studies, Utrecht, Netherlands
[4] Univ Utrecht, Dept Pharmaceut, UIPS, Utrecht, Netherlands
关键词
GENERIC SUBSTITUTION; EPOETIN-ALPHA; RENAL ANEMIA; SAFETY; NEED;
D O I
10.1038/nbt.2438
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 [微生物学]; 090105 [作物生产系统与生态工程];
摘要
For authorized biosimilars to achieve full acceptance in the marketplace, it is crucial that they are considered to be therapeutically equivalent and interchangeable with the brand reference product.
引用
收藏
页码:1186 / 1190
页数:5
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