Legislation (S 1695) that would create an FDA approval pathway for follow-on biologics would reduce federal health care spending by $5.9 billion and national spending on biotechnology drugs by $25 billion over the next 10 years, according to a Congressional Budget Office analysis released this week, CQ HealthBeat reports. CBO's estimates are similar to the findings of a study conducted last year by Avalere Health, which found that the legislation could save federal health care programs $3.6 billion over 10 years. Previous estimates had predicted that follow-on biologics could save the health care system up to $71 billion over 10 years, with $3.5 billion in savings during the first year.

Bill co-sponsor Sen. Michael Enzi (R-Wyo.) said, "This budget score confirms that our biosimilar therapeutics bill will save Americans billions of dollars in prescription drug costs." In a statement, Enzi said, "If the leadership of the House is serious about controlling long-term health costs, they will take steps to pass this legislation soon, not wait until the next Congress." The Senate Health, Education, Labor and Pensions Committee approved the bill last year.

Two bills have been introduced in the House that also would require an FDA approval pathway. One bill (HR 5629) by Rep. Anna Eshoo (D-Calif.) would allow for a 14-year period of data exclusivity, while another bill (HR 1038) by Rep. Henry Waxman (D-Calif.) contains no exclusivity period (McCarthy, CQ HealthBeat, 6/26).

The report is available online.