Intellectual Property: Path for Generic Competition Open in Biotechnology Industry

In the pharmaceutical industry, intense competition has been going on for years between "branded" drug manufacturers and "generic" competitors for the same drugs. This competition has taken place under the carefully balanced rules laid out in the Hatch-Waxman Act, with the biotechnology industry thus far immune to it. Thanks to the Biologics Price Competition and Innovation Act of 2009 and the long-awaited proposed "biosimilar" guidelines, issued by the U.S. Food and Drug Administration on Feb. 9, that is about to change.
TheLegalIntelligencer.com

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