REGULATORY REQUIREMENTS AND SCIENTIFIC RATIONALE FOR BIOSIMILAR: US VS. EUROPEAN UNION

被引：0
|
作者：
Barral, G. [1 ]
Mahi, L. [2 ]
机构：
[1] Axelys Sante, Malakoff, France
[2] Axelys Sante, Paris, France
来源：
VALUE IN HEALTH | 2018年 / 21卷
关键词：
D O I：
10.1016/j.jval.2018.09.542
中图分类号：
F [经济];
学科分类号：
02 ;
摘要：
PCP67
引用
收藏
页码：S92 / S92
页数：1
相关论文
共 50 条
  • [1] SCIENTIFIC RATIONALE & REGULATORY REQUIREMENTS FOR BIOSIMILARS: US VS. EUROPEAN UNION VS WHO
    Chibane, I
    Amrane, Y.
    Connan, C.
    Mahi, L.
    VALUE IN HEALTH, 2019, 22 : S288 - S288
  • [2] Regulatory and Clinical Experiences with Biosimilar Filgrastim in the US, the European Union, Japan, and Canada
    Chen, Brian
    Nagai, Sumimasa
    Armitage, James O.
    Witherspoon, Bartlett
    Nabhan, Chadi
    Godwin, Ashley C.
    Yang, Y. Tony
    Kommalapati, Anuhya
    Tella, Sri Harsha
    DeAngelis, Carlo
    Raisch, Dennis W.
    Sartor, Oliver
    Hrushesky, William J.
    Ray, Paul S.
    Yarnold, Paul R.
    Love, Bryan L.
    Norris, LeAnn B.
    Knopf, Kevin
    Bobolts, Laura
    Riente, Joshua
    Luminari, Stefano
    Kane, Robert C.
    Hoque, Shamia
    Bennett, Charles L.
    ONCOLOGIST, 2019, 24 (04): : 537 - 548
  • [3] An introduction to biosimilar cancer therapeutics: definitions, rationale for development and regulatory requirements
    Buske, Christian
    Ogura, Michinori
    Kwon, Hyuk-Chan
    Yoon, Sang Wook
    FUTURE ONCOLOGY, 2017, 13 (15) : 5 - 16
  • [4] Methodological developments vs. regulatory requirements
    Bauer, Peter
    BIOMETRICAL JOURNAL, 2006, 48 (04) : 609 - 612
  • [5] Key Regulatory Elements in Electric Power Industry: Russia vs. European Union
    Vasilyev, M. Yu.
    2009 6TH INTERNATIONAL CONFERENCE ON THE EUROPEAN ENERGY MARKET, 2009, : 293 - 298
  • [6] Regulatory requirements for medical devices in the European Union
    Eikelboom, BC
    Duijst, P
    EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY, 1996, 12 (01) : 3 - 4
  • [7] Methodological developments vs. regulatory requirements - Rejoinder
    Koch, Armin
    BIOMETRICAL JOURNAL, 2006, 48 (04) : 616 - 622
  • [8] Harmonization of US, European Union, and Canadian First-in-Human Regulatory Requirements for Radiopharmaceuticals: Is This Possible?
    Schwarz, Sally W.
    Decristoforo, Clemens
    Goodbody, Anne E.
    Singhal, Nikhita
    Saliba, Sarah
    Ruddock, Patrick S.
    Zukotynski, Katherine
    Ross, Andrew A.
    JOURNAL OF NUCLEAR MEDICINE, 2019, 60 (02) : 158 - 166
  • [9] EUROPEAN IDENTITY VS. NATIONAL IDENTITY? THE CRISIS OF IDENTIFICATION IN THE EUROPEAN UNION
    Irimie, Rada Cristina
    GLOBALIZATION AND INTERCULTURAL DIALOGUE: MULTIDISCIPLINARY PERSPECTIVES - POLITICAL SCIENCES, 2014, : 114 - 128
  • [10] Business union vs. business union? Understanding the split in the US labour movement
    Greer, Ian
    CAPITAL AND CLASS, 2006, 30 (03): : 1 - 6
12345