FDAnews Drug Daily Bulletin


June 5, 2006

In a citizen petition opposing FDA approval of Sandoz' follow-on human growth hormone Omnitrope, biotechnology firm Genentech asked the agency to notify drugmakers of any potential use of their drugs' safety and efficacy data, a move that would stymie the agency's efforts to draft a guidance for the manufacture of follow-on biologics.

Genentech said it does not want its data to be included in the "knowledge base" the FDA is compiling to craft the guidance and said it wants to be able to "intervene to stop such use or disclosure before it occurs."

The agency approved Omnitrope (somatropin rdna origin) early this week, after a nearly three-year delay that the FDA attributed to unresolved scientific, legal and regulatory issues. Omnitrope is a version of Pfizer's human growth hormone Genotropin.

But the FDA emphasized the approval does not create a regulatory pathway for the approval of all follow-on protein products or for follow-on biologics. While the agency rejected Genentech's assertion that it had to rely on proprietary data to approve Omnitrope, it did not address what it would need to establish a general approval pathway.

In its petition, Genentech objected to the FDA's "reference to or reliance on Genentech trade secret and confidential commercial data and information to approve a competitor's product. "The FDA has gained a tremendous amount of knowledge about biotechnology-derived products and the way they perform in the human body through reviewing the trade secret and confidential commercial data and information of companies like Genentech. (http://www.fdanews.com/did/5_108/)