Waxman, Hatch say biosimilars balance tipping to generics

Rep. Henry Waxman (D-Calif.), Sen. Orrin Hatch (R-Utah) and a member of Sen. Edward Kennedy's (D-Mass.) staff predicted Monday that biosimilars legislation will be enacted by the next Congress, and it will be more favorable to biosimilars manufacturers than is pending Senate legislation. Speaking at the Biosimilars 2008 conference in Washington, David Dorsey, a legislative assistant to Kennedy, said the 12-year data exclusivity period for innovator products in the Biologics Price Competition and Innovation Act of 2007 (S. 1695) set the "high-water mark" for exclusivity (See BioCentury Extra, Wednesday, June 27, 2007).

Waxman said he is unconvinced by BIO's arguments that a 14-year exclusivity period is needed to maintain incentives for innovation. He cited an academic study sponsored by Teva (NASDAQ:TEVA) that "makes a persuasive argument that an exclusivity period this long will decrease innovation." Hatch added that some biosimilar manufacturers are already looking to the next Congress for a "better deal" on issues like data exclusivity. ...