Generics Safe Harbor Question Could Derail Biosimilars

Law360, New York (August 21, 2012, 10:13 PM EDT) -- Biologic drug sponsors may have a powerful weapon to block competition from cheaper biosimilars, experts say, if they can successfully argue that the generic drug law's safe harbor from patent infringement expires the moment a drug wins regulatory approval.

Under the safe harbor provision, generics developers can use patented tests and procedures to create and test their generics as part of the regulatory approval process, without risking infringement suits from the original drug sponsors.

But the U.S. Food and Drug Administration sometimes requires post-market safety and...
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