Japanese regulatory authority's perspective on biosimilars reply

被引:0
|
作者
Bennett, Charles L. [1 ,2 ,3 ,4 ,5 ]
Chen, Brian [1 ,2 ,5 ]
Hermanson, Terhi [6 ]
Georgantopoulos, Peter [1 ,2 ,3 ,5 ]
Sartor, Oliver A. [7 ]
机构
[1] Univ S Carolina, South Carolina Coll Pharm, South Carolina Ctr Econ Excellence Medicat Safety, Columbia, SC 29208 USA
[2] Univ S Carolina, South Carolina Coll Pharm, SONAR, Columbia, SC 29208 USA
[3] WJB Dorn VA Med Ctr, Columbia, SC USA
[4] Hollings Canc Ctr, Charleston, SC USA
[5] Univ S Carolina, Arnold Sch Publ Hlth, Columbia, SC 29208 USA
[6] Univ Helsinki, Cent Hosp, Dept Oncol, Helsinki, Finland
[7] Tulane Univ, Sch Med, Tulane Canc Ctr, New Orleans, LA 70118 USA
来源
LANCET ONCOLOGY | 2015年 / 16卷 / 03期
关键词
FOLLOW-ON BIOLOGICS;
D O I
10.1016/S1470-2045(15)70047-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
引用
收藏
页码:E102 / E102
页数:1
相关论文
共 50 条
  • [1] Japanese regulatory authority's perspective on biosimilars
    Nagai, Sumimasa
    Yanagihara, Reiko
    Kishioka, Yasuhiro
    [J]. LANCET ONCOLOGY, 2015, 16 (03): : E101 - E101
  • [2] Health authority perspective on biosimilars
    Godman, Brian
    [J]. GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 2013, 2 (01): : 10 - 11
  • [3] Iraqi regulatory authority current system and experience with biosimilars
    Al-Kinani, Khalid K.
    Ibrahim, Mazin J.
    Al-Zubaidi, Ruaa F.
    Younus, Manal M.
    Ramadhan, Samir H.
    Kadhim, Hussein J.
    Challand, Rodeina
    [J]. REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2020, 117
  • [4] Biosimilars: a regulatory perspective from America
    Kay, Jonathan
    [J]. ARTHRITIS RESEARCH & THERAPY, 2011, 13 (03)
  • [5] Biosimilars: a regulatory perspective from America
    Jonathan Kay
    [J]. Arthritis Research & Therapy, 13
  • [6] Current Japanese Regulatory Systems for Generics and Biosimilars
    Kuribayashi, Ryosuke
    Sawanobori, Kenji
    [J]. JOURNAL OF PHARMACEUTICAL SCIENCES, 2018, 107 (03) : 785 - 787
  • [8] Safety assessment of biosimilars in Europe: a regulatory perspective
    Giezen, Thijs J.
    Schneider, Christian K.
    [J]. GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 2014, 3 (04): : 180 - 183
  • [9] REGULATORY IMPLICATIONS - AN AUTHORITY PERSPECTIVE
    CARTWRIGHT, AC
    [J]. BIOCHEMICAL SOCIETY TRANSACTIONS, 1991, 19 (02) : 465 - 467
  • [10] Regulatory toxicology from an authority perspective
    Kass, G. E.
    [J]. TOXICOLOGY LETTERS, 2022, 368 : S3 - S3