European perspective on biosimilars

被引：0
|
作者：
Wadhwa, Meenu [1 ]
Thorpe, Robin [1 ]
机构：
[1] NIBSC, Biotherapeut Grp, Potters Bar EN6 3QG, Herts, England
来源：
BIOANALYSIS | 2013年 / 5卷 / 05期
关键词：
comparability; global development; immunogenicity; reference product; reference standards; terminology; WHO; EFFICACY; SAFETY;
D O I：
10.4155/BIO.13.2
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
引用
收藏
页码：521 / 524
页数：4
相关论文
共 50 条
  • [31] Saving money in the European healthcare systems with biosimilars
    Haustein, Robert
    de Millas, Christoph
    Hoeer, Ariane
    Haeussler, Bertram
    GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 2012, 1 (3-4): : 120 - 126
  • [32] Biosimilars in the European Union: current situation and challenges
    Wolff-Holz, Elena
    Weise, Martina
    BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ, 2020, 63 (11) : 1365 - 1372
  • [33] Challenges for Streamlining the Development of Biosimilars: A Japanese Perspective
    Arato, Teruyo
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023, 113 (01) : 30 - 36
  • [34] Biosimilars versus 'biobetters'-a regulator's perspective
    Anour, Rene
    GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 2014, 3 (04):
  • [35] The case for biosimilars-a payer's perspective
    Befrits, Gustaf
    GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 2013, 2 (01): : 12 - 12
  • [36] Are There Benefits and Risks to Biosimilars from a Patient Perspective?
    Kay, Jonathan
    RHEUMATIC DISEASE CLINICS OF NORTH AMERICA, 2019, 45 (03) : 465 - +
  • [37] Japanese regulatory authority's perspective on biosimilars
    Nagai, Sumimasa
    Yanagihara, Reiko
    Kishioka, Yasuhiro
    LANCET ONCOLOGY, 2015, 16 (03): : E101 - E101
  • [38] Biosimilars: The Need, The Challenge, The Future: The FDA Perspective
    Epstein, Michael S.
    Ehrenpreis, Eli D.
    Kulkarni, Prasad M.
    AMERICAN JOURNAL OF GASTROENTEROLOGY, 2014, 109 (12): : 1856 - 1859
  • [39] Biosimilars from a practicing rheumatologist perspective: An overview
    Schimizzi, Gregory F.
    AUTOIMMUNITY REVIEWS, 2016, 15 (09) : 911 - 916
  • [40] Safety assessment of biosimilars in Europe: a regulatory perspective
    Giezen, Thijs J.
    Schneider, Christian K.
    GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL, 2014, 3 (04): : 180 - 183
12345