Biosimilars: the impact of their heterogeneity on regulatory approval

被引：0
|
作者：
Asterios S Tsiftsoglou
机构：
[1] Professor of Pharmacology,
[2] Aristotle University of Thessaloniki,undefined
[3] Thessaloniki,undefined
[4] Greece,undefined
[5] and Core Member of Biologics Working Party (BWP) and European Medicines Agency (EMEA),undefined
来源：
Nature Reviews Drug Discovery | 2007年 / 6卷 / 3期
关键词：
D O I：
10.1038/nrd2093-c1
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：252 / 252
相关论文
共 50 条
  • [1] Global Regulatory Standards for the Approval of Biosimilars
    Mounho, Barbara
    Phillips, Audrey
    Holcombe, Kay
    Grampp, Gustavo
    Lubiniecki, Tony
    Mollerup, Inger
    Jones, Carolyn
    FOOD AND DRUG LAW JOURNAL, 2010, 65 (04) : 819 - 837
  • [2] The Complexities of Biosimilars and the Regulatory Approval Process
    Lucio, Steven
    AMERICAN JOURNAL OF MANAGED CARE, 2018, 24 (11): : S231 - S236
  • [3] Approval of biosimilars: a review of unsuccessful regulatory filings
    Rathore, Anurag S.
    Chhabra, Hemlata
    Bhargava, Ankita
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2021, 21 (01) : 19 - 27
  • [4] The US Biosimilars ActChallenges Facing Regulatory Approval
    Cecil Nick
    Pharmaceutical Medicine, 2012, 26 (3) : 145 - 152
  • [5] Regional regulatory processes for the approval of biosimilars; differences and similarities
    Thorpe, Robin
    GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 2014, 3 (03):
  • [6] Biosimilars: Approval and Acceptance?
    DeMartino, Jessica K.
    JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK, 2011, 9 : S6 - S9
  • [7] Biosimilars approval process
    Zuniga, Leyre
    Calvo, Begona
    REGULATORY TOXICOLOGY AND PHARMACOLOGY, 2010, 56 (03) : 374 - 377
  • [8] Regulatory Approval Scenario of Biosimilars in Pediatric Patients in the United States and European Union
    Radhakrishna, Swetha
    Dahiya, Meghana
    Pipalava, Parag
    Jose, Vinu
    PHARMACEUTICAL MEDICINE, 2021, 35 (02) : 93 - 112
  • [9] Regulatory Approval Scenario of Biosimilars in Pediatric Patients in the United States and European Union
    Swetha Radhakrishna
    Meghana Dahiya
    Parag Pipalava
    Vinu Jose
    Pharmaceutical Medicine, 2021, 35 : 93 - 112
  • [10] Translating European regulatory approval into healthcare uptake for biosimilars: the second translational gap
    Acha, Virginia
    Mestre-Ferrandiz, Jorge
    TECHNOLOGY ANALYSIS & STRATEGIC MANAGEMENT, 2017, 29 (03) : 263 - 275
12345