Tempers rise as biosimilar debate reaches a boil

Billions of dollars in prospective biotech earnings will be riding on the Senate Health, Education, Labor and Pensions Committee this week as it reviews a new bill from Senator Ted Kennedy that would provide 13.5 years of IP protection for biologics. That's about twice the amount of exclusivity prescribed by the Obama administration, but industry lobbyists tell the Wall Street Journal that's what would be needed to keep developers on board with a compromise healthcare reform law.

With biologics on track to hit the $100 billion mark in 2011, the debate in Washington has triggered an advertising war between PhRMA and BIO on one side and the AARP and its allies on the other. Short exclusivity periods sell out American workers, claim the developers, by triggering job losses and the export of U.S. jobs to generic drug makers in India and China. AARP, meanwhile, says any "double digit" exclusivity period would force the influential group to oppose the reform package.

The discussion over biosimilars has also raised temperatures among lawmakers with widely divergent opinions on the subject. "Biotechnology start-up involves high risk and high cost, but you can't give these companies open-ended protection from generics," said Sen. Sherrod Brown.

- check out the story from the Wall Street Journal

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