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Waxman asks Obama to look for alternative pathway for biosimilars


WASHINGTON With biosimilars legislation stalling in both houses of Congress, one of its chief proponents is calling on the Obama administration to let the Food and Drug Administration approve the legistlations with or without a regulatory pathway, according to published reports.

The Associated Press reported Monday that Rep. Henry Waxman, D-Calif., has asked the administration to look for ways to grant approval for biosimilars before either of the bills passes, to allow the FDA to approve them.

Waxman -- who co-sponsored the Hatch-Waxman Act of 1984, creating a regulatory pathway for generic pharmaceutical drugs -- introduced a bill on March 11 to allow biosimilars. That bill, H.R. 1427, would grant biotech companies five years’ market exclusivity before their products faced biosimilar competition. Waxman’s bill, with 11 co-sponsors and a companion bill in the Senate, competes with fellow California Democratic Rep. Anna Eshoo’s H.R. 1548, introduced six days after Waxman’s, which would grant up to 14 years of exclusivity to biotech companies and had 87 co-sponsors in the House as of Tuesday.

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