FDA chief finds biogenerics path complex

By Lewis Krauskopf

WASHINGTON (Reuters) - The head of the U.S. Food and Drug Administration said on Monday that finding an approval path for generic versions of biotech drugs has been more complex than he had thought.

The U.S. government has been under pressure to pave the way for low-cost generic versions of biotech drugs. Such therapies are more complicated to manufacture than standard chemical medicines.

Dr. Andrew von Eschenbach, confirmed as FDA commissioner last month after serving as acting chief for more than a year, predicted the agency would move "incrementally, and it may take a long time to get to some very complex proteins."

"We do want to move toward generic biologics and getting them out," von Eschenbach said, speaking at the Reuters Regulation Summit in Washington. "We just won't be able to do it as a one-size fits all and there will be a magic moment in time when it all happens."

Von Eschenbach said he underestimated the complexity of the issue when he was in his prior job as head of the National Cancer Institute.

"Even slight changes in manufacturing processes, where the temperature can be altered just a little bit, winds up with you having a much different product coming out the other end," von Eschenbach said. "I have to admit that even I wasn't as tuned into that degree of complexity."

So-called "biogenerics" could provide cost savings for insurers and patients, who pay thousands of dollars for branded biotech drugs. Such medicines are typically injected because they involve large proteins and treat conditions such as anemia and rheumatoid arthritis.

Teva Pharmaceutical Industries Ltd. (TEVA.O: Quote, Profile, Research, Stock Buzz), Barr Laboratories Inc. (BRL.N: Quote, Profile, Research, Stock Buzz) and Novartis AG (NOVN.VX: Quote, Profile, Research, Stock Buzz) are among the leaders in the emerging biogenerics field.

Critics have said the United States has been slow in developing a way to bring biogenerics to the market, especially compared with Europe.

"Most people think we are just dragging our heels," von Eschenbach said. "But what I've learned in talking to people within the FDA is this is really tough stuff."