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Regulatory Focus™ > News Articles > FDA to Approve New Generics, But Health Care Savings Will Be Minimal

FDA to Approve New Generics, But Health Care Savings Will Be Minimal

Posted 05 December 2011

By the end of 2011 the US Food and Drug Administration (FDA) plans to release a set of guidelines to approve generic versions of biological drugs-a newer breed of pharmaceuticals that includes enzymes, antibodies and other molecules derived from living cells.  Although biological generics will be less expensive than brand-name biologicals, they are expected to still be expensive. Under the Hatch-Waxman Act, as long as a manufacturer proved its generic drug was chemically identical to the pioneer drug, the generic could piggyback on the pioneer's clinical research. By avoiding those expensive animal and human trials to assess the drug's safety and efficacy, generic drugs were able to cut costs by up to 80 percent. Lowering prices will not be so easy for biological generics, however, largely because they will have a harder time avoiding those costly clinical trials because biological drugs are bigger and more complicated than traditional drugs and their production relies on sensitive manufacturing processes. (Scientific American)

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