Published Online: Wednesday, August 1, 2007

Senate leaders responsible for hammering out new legislation creating an expedited pathway for the approval of follow-on biologic drugs are showing little appetite for grappling with the prickly issue of whether sponsors of lower-cost biogenerics should be required to repeat the clinical testing performed by manufacturers of the branded version. Genericdrug industry leaders regard a clinicaltrial requirement as a key impediment to expeditious FDA approval of biogenerics, but others argue that such testing is essential to protect the public.

An early draft of the bill being prepared in the Senate, however, avoids that issue by leaving it up to the FDA to determine whether clinical trials are needed on a case-by-case basis. The bill is being drafted by a Senate group that includes Sens Orrin Hatch (R, Utah), Hillary Rodham Clinton (D, NY), Edward Kennedy (D, Mass), and Mike Enzi (R, Wyo).

Generic-pharmaceutical industry officials are seeking language that would give brand name biologics no more than 12 years of market exclusivity before a generic challenger could enter the market. Under that timetable, some biologics now on the market could face immediate generic competition because they were approved prior to 1995.

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