DNA wants biogeneric block

Genentech (DNA) filed a Citizen Petition with FDA requesting that the agency refrain from issuing a draft guidance document on biogenerics, and from approving a biogeneric product characterized as "similar to or the same as" a DNA product based on findings that rely on DNA's trade secrets and commercial data. DNA also asked FDA to develop a process to notify the company of potential use of its trade secrets or commercial data and to allow the company to intervene to stop such use.

FDA is developing draft guidance for industry describing how to determine the similarity of protein molecules. DNA said that because each biotech product is "inexorably linked to and inseparable from the manufacturing processes used in its creation," it does not believe that similarity can be determined without relying on proprietary manufacturing data from innovator companies. Specifically, DNA said that it does not believe FDA can approve a biogeneric product based on "findings" about a DNA product without "relying -- directly or indirectly -- on trade secret and confidential commercial data and information DNA provided to FDA for an explicitly limited purpose." ...