Why an abbreviated FDA pathway for biosimilars is overhyped
نویسندگان
چکیده
منابع مشابه
In U.S., biosimilars still await FDA decision.
Offi cials at the U.S. Food and Drug Administration have yet to announce if and when they plan to begin accepting abbreviated applications for follow-on biologics (referred to as " biosimilar " drugs in Europe), but experts said they do not expect anything from the agency soon. Generic biologic agents can still be approved through a new-drug application (NDA), but the burden of proof that comes...
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1Division of Clinical Pharmacology, Department of Medicine and Therapeutics Hong Kong Institute of Diabetes and Obesity, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong 2Clinical Research Management Office, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong 3Department of Clinical Oncology at the Sir YK Pao Centre for Cancer Hong Ko...
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ژورنال
عنوان ژورنال: Nature Biotechnology
سال: 2011
ISSN: 1087-0156,1546-1696
DOI: 10.1038/nbt.1960