European medicines agency guideline for biological medicinal products: a further step for a safe use of biosimilars

被引:2
作者
Carlo Agostini
Giorgio Walter Canonica
Enrico Maggi
机构
[1] University of Padua,Department of Medicine
[2] University of Genoa,Department of Clinical and Experimental Medicine
[3] IRCCS AOU San Martino-IST,undefined
[4] University of Florence,undefined
关键词
European Medicine Agency; Reference Product; Biosimilar Product; Biopharmaceutical Company; Biological Medicinal Product;
D O I
10.1186/s12948-015-0010-3
中图分类号
学科分类号
摘要
引用
收藏
相关论文
共 16 条
[1]  
Gommolon F(2014)Biosimilars: are they bioequivalent Dig Dis 32 82-7
[2]  
Braido F(2012)From “blockbusters” to “biosimilars”: an opportunity for patients, medical specialists and health care providers Pulm Pharmacol Ther 25 483-6
[3]  
Holgate S(2014)Regulatory and clinical considerations for biosimilar oncology drugs Lancet Oncol 15 e594-605
[4]  
Canonica GW(2014)Systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutic: committee recommendations for the development and validation of a single ligandbinding assay to support pharmacokinetic assessments AAPS J 16 1149-58
[5]  
Bennett CL(undefined)undefined undefined undefined undefined-undefined
[6]  
Chen B(undefined)undefined undefined undefined undefined-undefined
[7]  
Hermanson T(undefined)undefined undefined undefined undefined-undefined
[8]  
Wyatt MD(undefined)undefined undefined undefined undefined-undefined
[9]  
Schulz RM(undefined)undefined undefined undefined undefined-undefined
[10]  
Georgantopoulos P(undefined)undefined undefined undefined undefined-undefined