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Journal of the National Cancer Institute Advance Access originally published online on August 28, 2007
JNCI Journal of the National Cancer Institute 2007 99(17):1286-1287; doi:10.1093/jnci/djm147
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© Oxford University Press 2007.

NEWS

Generic Biologics May Be Coming to the Marketplace If Legislation Passes In Congress

Joel B. Finkelstein

The first 10% of the full text of this article appears below.

Legislation currently moving through the Senate would allow the U.S. Food and Drug Administration to regulate generic biologic agents, an industry potentially worth billions of dollars a year. But it would also establish protections that favor the original developers, giving them 12 years without direct competition.

Although a relatively young field, there are already a handful of blockbuster biologic agents, especially in oncology, where these treatments promise a more targeted approach to the disease. Everything from blood and blood products to cellular and gene therapies falls under the FDA's definition of protein products, or biologics, which the agency regulates under different authority from that of standard drugs because of their unique complexity. Both the structure and manufacture of biologics, also called . . . [Full Text of this Article]


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