Barr CEO sees U.S. biogenerics in 5 years

By Lewis Krauskopf and Ben Hirschler

NEW YORK (Reuters) - Generic versions of expensive biotech drugs should reach the U.S. market within five years, as lawmakers create rules authorizing their entry, the chief executive of Barr Pharmaceuticals Inc. (BRL.N: Quote, Profile, Research, Stock Buzz) said on Tuesday.

Bruce Downey said his company has 10 such "biogenerics" in development following Barr's recent acquisition of Croatian drugmaker Pliva PLVxq.L, a specialist in the field.

U.S. regulators have said they do not have the authority to approve generic forms of drugs that are derived from naturally occurring proteins, known as biologics, leading to calls by some politicians for laws to allow their launch.

Such medicines are more complicated to manufacture than standard chemical drugs, making it difficult to determine whether they are equivalent to the originals.

"I think we could see products on the market in five years," Downey told the Reuters Health Summit in New York. "I'd be disappointed if we don't."

The U.S. Food and Drug Administration for years has promised to come up with guidelines by which it could clear the way for biogenerics, but so far has failed to do so, citing a lack of enabling legislation.

"I think certain members of the FDA have a bias against it ... People who work in organizations like the FDA tend to be very conservative and hesitant to change, sort of by disposition," Downey said.

Biogenerics could provide big cost savings for insurers and patients, who pay up to thousands of dollars for branded biotech drugs, which are typically injected because they involve large proteins that are destroyed by the stomach.  Continued...