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Congress mulls generics for biologic drugs
March 8, 2007

The U.S. Senate is holding hearings this week on a bill which would give the FDA the ability to approve generic versions of biologic drugs. If approved, the measure could potentially save the federal health programs $71 billion over the next ten years, according to some estimates. To date, the FDA has said that it doesn't have the power to approve generic versions of these very expensive drugs, which include insulin, human growth hormone and therapies that treat multiple sclerosis. (It did approve Novartis' human growth hormone copycat Omnitrope last year.) But the new bill, which is sponsored by Democratic senators Charles E. Schumer and Hillary Clinton, would allow these generics to come onto the market quickly if they're "comparable" to the brand-name drug. Critics--particularly branded drug makers--have long held that biologic therapies are too complex to permit knockoffs from competing with them.

The proposed legislation has garnered strong support from employers like General Motors, whose healthcare budgets are being strained by the cost of biologics treatments. Sen. Edward M. Kennedy, meanwhile, expressed support for a more conservative approach--along the lines of that taken by European regulators--in which the requirements for approval of generic biologics would vary depending on the complexity of the drug. Critics of Kennedy's proposal note that such additional requirements could add millions to the cost of developing generic biologics.

To learn more about the debate:
- read this article from The Boston Globe