FDA challenges GPhA and broaches subject of user fees; Biosimilars approval unlikely until 2009

Today, Scott Gottlieb, FDA's Deputy Commissioner for Medical and Scientific Affairs, spoke before the Generic Pharmaceutical Association, responding to the association's criticism of the Agency's generic drug approval process and funding for the Office of Generic Drugs (OGD).  He challenged generic drug makers to examine the "root causes" for failed applications, singling out the need for better communication with their API suppliers outside the U.S., to ensure the quality of Drug Master Files. He also brought up the issue of user fees for generic drugs. Among the points he made:

• OGD's budget has doubled since 2001, staffing has increased and will rise again this year
• Since 1996, the average time for approval has dropped 40% to 16 months
• Sponsors should use the dissolution data posted on the Internet in their applications.
• Complete applications result in multiple review cycles. Last year, 93% of generic applications were rejected during the first cycle, and 59% during the second cycle.

Mr. Gottlieb also emphasized the need for better science, which would establish generic equivalence, not only for biologics, but also for inhaled medicines and liposomal drugs. Biogenerics would be a multi-billion-dollar market, but FDA approval has been in limbo for some time, prompting Sandoz to sue FDA last year over its refusal to approve the human growth hormone follow on, Omnitrope. The EU has already approved the compound. A guidance document may be issued sometime this year, Angelo De Palma writes in an upcoming article in March's issue of Pharmaceutical Manufacturing magazine, but full approval is probably at least three years away.  Although the science of protein diagnostics is improving, Dr. De Palma writes, follow-on biologics manufacturers in the U.S. may have to prepare themselves for the prospect of clinical trials.  Although most project a market in the $5-to-$10-billion range, one financial analyst expects the biosimilars market to reach $50 billion. -AMS