FDA Reviews Process For Approving Biotech Generics

Law360, New York (February 18, 2004, 12:00 AM EST) -- The Food and Drug Administration is laying the early groundwork for approving generic versions of biotechnology medicines, a policy move riddled with controversy, according to a published report.

The agency is preparing scientific guidelines on how to prove that copies are similar to the original medicines, the Wall Street Journal reported in its Wednesday edition.

The move comes as some of the oldest biotech drugs, such as Eli Lilly & Co.'s bioengineered insulin Humulin and Genentech Inc.'s Nutropin growth hormone, are beginning to lose their patent...
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