FDA and EMA Biosimilar Approvals

被引:13
|
作者
Jung, Emily H. [1 ,2 ]
Sarpatwari, Ameet [1 ,2 ]
Kesselheim, Aaron S. [1 ,2 ]
Sinha, Michael S. [1 ,2 ,3 ]
机构
[1] Brigham & Womens Hosp, Dept Med, Div Pharmacoepidemiol & Pharmacoecon, Program Regulat Therapeut & Law PORTAL, 75 Francis St, Boston, MA 02115 USA
[2] Harvard Med Sch, Boston, MA 02115 USA
[3] Harvard Med Sch, Harvard MIT Ctr Regulatory Sci, Boston, MA 02115 USA
关键词
D O I
10.1007/s11606-019-05408-6
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
[No abstract available]
引用
收藏
页码:1908 / 1910
页数:3
相关论文
共 50 条
  • [1] FDA and EMA Biosimilar Approvals
    Emily H. Jung
    Ameet Sarpatwari
    Aaron S. Kesselheim
    Michael S. Sinha
    [J]. Journal of General Internal Medicine, 2020, 35 : 1908 - 1910
  • [2] The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
    Gherghescu, Ioana
    Delgado-Charro, M. Begona
    [J]. PHARMACEUTICS, 2021, 13 (01) : 1 - 16
  • [3] FDA and EMA Biosimilar Approvals (December, 10.1007/s11606-019-05408-6, 2019)
    Jung, Emily H.
    Sarpatwari, Ameet
    Kesselheim, Aaron S.
    Sinha, Michael S.
    [J]. JOURNAL OF GENERAL INTERNAL MEDICINE, 2019,
  • [4] Marketing approvals for cell and gene therapy products in oncology: Current review of EMA and FDA approvals
    Chandaria, Rehma
    Sripathirathan, Kumar
    Song, Yun Jeong
    Learn, Chris A.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2023, 41 (16)
  • [5] Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA
    Amaral, Carolina
    Rodrigues, Ana Rita
    Veiga, Francisco
    Bell, Victoria
    [J]. APPLIED SCIENCES-BASEL, 2024, 14 (17):
  • [6] Requirements for biosimilar authorization: a legal and comparative perspective - FDA versus EMA
    Noguera Pena, Alfonso
    del Castillo Rodriguez, Carlos
    [J]. CURRENT SCIENCE, 2021, 120 (01): : 56 - 65
  • [7] FDA and EMA Approvals of New Breast Cancer Drugs-A Comparative Regulatory Analysis
    Leo, Chandra P.
    Hentschel, Bettina
    Szucs, Thomas D.
    Leo, Cornelia
    [J]. CANCERS, 2020, 12 (02)
  • [8] Expanded Access as a source of real-world data: An overview of FDA and EMA approvals
    Polak, Tobias B.
    van Rosmalen, Joost
    Uyl-de Groot, Carin A.
    [J]. BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2020, 86 (09) : 1819 - 1826
  • [9] FDA approvals
    不详
    [J]. AMERICAN FAMILY PHYSICIAN, 2003, 67 (12) : 2629 - 2629
  • [10] FDA approvals
    不详
    [J]. GERIATRICS, 2000, 55 (10) : 20 - 20