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Pharma Blog Watch

February 14, 2007

Generic Biologics Bill (GoozNews)
In his blog, Merrill Goozner discusses a bill introduced by Rep. Henry Waxman (D-Calif.) that "provides the Food and Drug Administration with a roadmap for approving generic biologics."

"The Biotechnology Industry Association claims that each cell line used to manufacture biologics is different and therefore needs to go through all the same clinical trials as the original drug to prove comparable efficacy. The FDA has so far gone along with that logic, and as a result, some of the original biologics, like Amgen's Epogen, are now well into their third decade of patent protection."

"It should be an interesting fight. We can worry about a Bush veto later."