Genentech Asks FDA TO Hold Off Biogenerics Policy Paper

Law360, New York (May 5, 2004, 12:00 AM EDT) -- Biotech company Genentech has filed a petition with the U.S. Food and Drug Administration, asking the agency to hold off on the release of its much-anticipated plan for approving generic biological drugs.

Genentech’s petition argues that it would be impossible for the FDA to release the plan or approve generic versions of its drugs without infringing on the company’s trade secrets.

"We draw the line at agency reference to or reliance on Genentech trade secret and confidential commercial data and information to approve a competitor's product,"...
To view the full article, register now.