Calling it a "generous compromise," the Obama administration says that biotech drugs should be given seven years of market exclusivity before facing competition from biosimilars. And the White House reiterated its position that getting lower prices on therapeutics is a "key element" in the administration's bid for healthcare reform, according to a letter obtained by Bloomberg.
The offer of seven years of exclusivity is unlikely to draw much support from developers, though, who have been insisting on a much more generous 12 to 14 years of protected status. BIO and other groups say that the development process would be badly damaged if lawmakers open a window to biogeneric competition much earlier, with investors likely to turn skittish in the face of high risk and limited exclusivity. But with the bill for biologics in the U.S. already topping $60 billion and rising fast, the pressure on legislating a regulatory pathway for biosimilars is growing.
"Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs," wrote Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget, in the letter written up by Bloomberg. Rep. Henry Waxman, meanwhile, has been pushing a bill that provides five years of exclusivity.
- read the report from Bloomberg