Biosimilars: part 1: proposed regulatory criteria for FDA approval.
نویسنده
چکیده
Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.
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عنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 38 5 شماره
صفحات -
تاریخ انتشار 2013