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Letter urges Waxman to push for provisions in H.R. 1427 for biosimilars regulatory pathway


WASHINGTON In a letter Friday, a group of organizations urged a Congressman to push for provisions contained in a bill he introduced that would create a regulatory pathway for biosimilars if a House committee calls for a pathway as part of healthcare reform legislation.

The Generic Pharmaceutical Association, AARP, the Pharmaceutical Care Management Association, labor unions and other groups asked Rep. Henry Waxman, D-Calif., to try and insert provisions from his Promoting Innovation and Life Saving Medicines Act in health reform legislation, if the legislation includes a pathway for biosimilars.

Waxman’s bill, introduced on March 11, would grant biotech drugs five years of market exclusivity, much like the Hatch-Waxman Act he co-sponsored in 1984, which created an approval pathway for generic pharmaceutical drugs.

Nevertheless, the bill has garnered only 14 co-sponsors, compared to 137 for the Pathway for Biosimilars Act, a competing bill introduced days after Waxman’s by Rep. Anna Eshoo, D-Calif., which would allow 12 to 14 years of exclusivity. Earlier this month, the Senate Health, Education, Labor and Pensions Committee voted to amend the healthcare reform bill to allow 12 years of exclusivity for biotech drugs.

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