Biogenerics Legislation To Be Tabled in 2007
Biogenerics legislation will likely be tabled until 2008, reported the Kaiser Daily Health Policy Report.
According to the Kaiser Daily Health Policy Report:
Rep. Henry Waxman (D-Calif.) in a speech before the Generic Pharmaceutical Association on Thursday said legislation (HR 1038) that would allow FDA to approve generic versions of biotechnology drugs is unlikely to reach the House floor this year. . . .
Waxman said that although “enormous strides” have been made since he introduced the measure in February, scheduling issues would prevent the bill from being included in House legislation (HR 2900) that would overhaul FDA and reauthorize prescription drug user fees. Waxman tried to attach the generic biotech measure to the FDA overhaul bill in July but was unsuccessful.
The biotech industry can breathe a sigh of relief. With the battle over patent reform legislation looming ahead this fall, biogenerics is one fight that the industry will not have to take on this year.
Comment from karthikeyan
Time October 5, 2007 at 5:53 am
hello sir
what are all the existing techniques atpresent to characterize the biogenerics without going for clinical trial or testing.