FDA looking to day when biotech drugs go off patent

02/18/2004 | Wall Street Journal, The

The oldest biotech drugs are starting to lose patent protection, and the FDA is preparing scientific guidelines for the proof needed to show that generics are similar to the original drugs, a more complicated process for biotechnology medicines. A major policy battle is developing, with biotech companies arguing their medicines are too complex for duplication without extensive tests while generic makers say they can make safe and effective copies and cut the costs of expensive biotech drugs.

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Wall Street Journal, The

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