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FOB debate awaits Kennedy/Enzi bill

Executive Summary

Rep. Henry Waxman's follow-on biologics bill arrives in the Senate March 26, courtesy of Chuck Schumer, D-N.Y., as S. 726, with three Republican and four Democrat co-sponsors, including Schumer. Meanwhile, Waxman is now joined by two Democrats and four Republicans in backing H.R. 1427. This compares to 54 co-sponsors signing on to Rep. Anna Eshoo's H.R. 1548 (1"The Pink Sheet" DAILY, March 18, 2009). Biosimilars legislation reported by the Senate Health, Education, Labor and Pensions Committee in 2008 will be re-introduced by Sens. Ted Kennedy, D-Mass., and Michael Enzi, R-Wyo., as soon as an agreement is reached on language to clarify how biologics can be modified and still qualify as innovative and gain 12 years of data exclusivity
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