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Biologics
Study results from Duke University broaden understanding of biologics
August 30th, 2008
According to recent research published in the journal Nature Reviews Drug Discovery, "Legislation to create a regulatory pathway for follow-on biologics is currently being considered by the United States Congress. A critical issue in this respect is the period of data exclusivity for innovator companies before a follow-on competitor can rely in part on data obtained for an original biologic for an abbreviated approval." "Given the nature of patents on biologics, the period of data exclusivity is anticipated to have a key role in determining how quickly follow-on competitors emerge, and consequently also on the time available for originator companies to recoup...
Source: Law & Health Weekly (2008-08-30)
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