A top drug regulator told lawmakers Monday it could be a decade or more before science is available to safely approve generic versions of biotech drugs as easily as traditional drugs. Food and Drug Administration deputy commissioner Janet Woodcock's testimony could benefit companies such as Amgen and Genentech, which have never faced generic competition in the U.S. That lack of competition would change under a recently introduced bill that would task FDA with approving generic versions of biotech medicines.
March 27, 2007 at 12:00 AM
1 minute read
The original version of this story was published on Law.Com
A top drug regulator told lawmakers Monday it could be a decade or more before science is available to safely approve generic versions of biotech drugs in the way the agency approves knockoffs of traditional drugs.
Food and Drug Administration deputy commissioner Janet Woodcock’s testimony could benefit companies such as Amgen Inc. and Genentech Inc., which have never faced generic competition in the U.S. for their products, some of the most complex and expensive on the market.
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