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Momentum builds for biogenerics, execs say

Fri Nov 16, 2007 1:11pm EST

Reporter's Notebook

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By Lewis Krauskopf

NEW YORK (Reuters) - Despite the failure by U.S. legislators to create a path this year for generic versions of biotech drugs, companies that have invested in the products say such legislation could pass in 2008 and yield generic biologics early in the next decade.

Momentum is clearly building, generic drugmakers and other companies that could benefit from the arrival of generic biologics said at the Reuters Health Summit in New York this week.

"The wind is at our back," Barr Pharmaceuticals Inc BRL.N Chief Executive Bruce Downey said. "We've really turned a corner in the last 15 months, and I think we're well on our way to seeing legislation."

U.S. legislators have been debating bills to create a pathway to approve generic forms of many drugs that are derived from naturally occurring proteins, known as biologics.

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

"I really believe in '08 some type of legislation will be passed," said Hospira Inc (HSP.N: Quote, Profile, Research, Stock Buzz) CEO Chris Begley.

Others said it was difficult to predict the legislative process, especially in an election year, but were no less upbeat about an eventual law.

"You can't predict what's going to go on in Congress, but I do think it's starting to resonate," said Thomas Ryan, CEO of CVS Caremark Corp (CVS.N: Quote, Profile, Research, Stock Buzz), the drug store chain and pharmacy benefit manager.

"It's always a little difficult to predict anything for an election year," said George Barrett, CEO of Teva North America. But, Barrett said, "The train is out of the station on that one. I think it's going to happen, and the question is a timing one."

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

The drugs treat conditions like anemia, rheumatoid arthritis, hepatitis and cancer.

Teva's Barrett said whether a law passes in 2008 or 2009 is not that critical as long as there is some movement.

"If you look at the patent cycle and you look at the development of products in biotechnology, the really big opportunity is actually in the U.S. probably early-to-mid next decade," Barrett said.

"In order to create value in the system during that time, you have got to start the ball rolling now," Barrett said.

Barr's Downey said the first drugs to use a new pathway could reach the U.S. market by 2011 or 2012.  Continued...

 
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