Takings issues in the approval of generic biologics.
نویسنده
چکیده
منابع مشابه
Follow-on biologics: challenges of the "next generation".
The imminent patent expiration of many biopharmaceutical products will produce the possibility for generic versions of these therapeutic agents (i.e. biosimilars). However, there are a number of issues that will make approval of biosimilars much more complicated than the approval of generic equivalents of conventional pharmaceuticals. These issues centre on the intrinsic complexity of biopharma...
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INTRODUCTION In 2009, the Biologics Price Competition and Innovation Act (BPCIA) paved the way for market entry of generic biologics by establishing a pathway for their regulatory approval. Proliferating with the advent of recombinant DNA technology, biologic drugs are derived from living organisms to create vaccines, blood products, allergenic products, monoclonal antibodies, cytokines, growth...
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When (if ever) a judicial action can be an unconstitutional taking of private property has long been an open question in American constitutional law. Nested within this larger question are a host of detailed issues concerning both substance and procedure. Despite passing references in some cases, and a more direct discussion in one concurring opinion, the Supreme Court of the United States—unti...
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Patents for several blockbuster biological products are expected to expire soon. The Food and Drug Administration is examining whether biologics can and should be treated like pharmaceuticals with regard to generics. In contrast with pharmaceuticals, which are manufactured through chemical synthesis, biologics are manufactured through fermentation, a process that is more variable and costly. Re...
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Biologic drugs represent an important new category of drugs in the effort to improve health outcomes in this country. Yet, these cutting-edge drugs are often cost prohibitive, preventing access for many Americans. Recognizing the need for more affordable, generic substitutes for biologic drugs—or biosimilars—Congress recently created a biosimilars approval pathway that would enable these cheape...
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ورودعنوان ژورنال:
- Food and drug law journal
دوره 60 1 شماره
صفحات -
تاریخ انتشار 2005