FDA chief urges generic biologic path

WASHINGTON (Reuters) - An approval path for generic versions of expensive biotechnology medicines should give regulators flexibility to determine testing requirements and protect innovation by brand-name makers, the head of the U.S. Food and Drug Administration said on Tuesday.

FDA Commissioner Andrew von Eschenbach told the Reuters Regulation Summit that the agency wanted Congress to create a pathway so more generic versions of the biotech medicines, or biologics, could be approved. But he also said science was evolving and the agency may not yet be able to evaluate copies of some of the most complex products.

Making the drugs interchangeable with branded versions, as the FDA does with traditional chemical drugs, would carry risks such as the possibility of allergic reactions, he added.

President George W. Bush's fiscal 2009 budget proposal, released on Monday, called on Congress to create a legal path for approval of generic biologics.

(For summit blog: summitnotebook.reuters.com/)

(Reporting by Lisa Richwine and Kim Dixon; Editing by Tim Dobbyn)