FDAnews Drug Daily Bulletin

Senate Panel Approves Healthcare Bill With 12-Year Biosimilar Exclusivity

July 17, 2009
A healthcare overhaul bill that would give innovator biologics 12 years of data protection and create two comparative-effectiveness research centers was passed by the Senate Health, Education, Labor and Pensions (HELP) Committee. The Affordable Health Choices Act, which passed by a 13–10 vote, is the first congressional healthcare overhaul bill to advance out of committee. The bill would allow an innovator product only one period of data exclusivity to prevent innovators from making minor changes to a product to obtain another 12-year period of exclusivity.
Drug Industry Daily