House Committee Supports 12-Year Data Exclusivity Period for Biologics

August 3, 2009

The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC).

The House Energy and Commerce Committee approved a legislative amendment that would give 12-years data exclusivity to innovator biologics. The amendment was introduced by Reps. Anna Eshoo (D-CA) and Jay Inslee (D-DC).

The House Committee voted 47–11 in favor of the amendment to the healthcare reform legislation, America’s Affordable Health Choices Act (HR 3200), before the start of the August recess. In July, the Senate Health, Education, Labor and Pensions (HELP) Committee had adopted the 12-year data exclusivity amendment to the healthcare legislation.

Rep. Henry Waxman (D-CA) has pushed for getting biosimilars to the market in five to seven years whereas Rep. Eshoo has said drug companies need a 12-year data exclusivity period.

Previous coverage:Senate Committee Approves Healthcare Bill with 12-Year Data Exclusivity for Innovator Biologics

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