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Volume 357:841-843 August 30, 2007 Number 9 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Biopharmaceutical products, with U.S. sales in 2006 amounting to about $40.3 billion, are increasingly central to the treatment of major health problems affecting Americans.¹ Since modern biopharmaceuticals date back to the 1980s, the first generation of such drugs has begun to lose patent protection (see table). In other parts of the world, governments have crafted regulations defining the terms of competition from "imitator," or generic, products. Many analysts have expressed concern that without new U.S. regulations, patent expirations may not be accompanied by the introduction of competing, lower-cost biologic agents — or that imitator products might be approved without . . . [Full Text of this Article]

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Dr. Frank is a professor of health economics at Harvard Medical School, Boston.

An interview with Senator Orrin Hatch (R-UT) can be heard at www.nejm.org.

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