GPhA urges removal of 12-year exclusivity amendment from healthcare-reform bill

NEW YORK Either reduce the amount of time that a drug company would have to wait before submitting an approval application to the Food and Drug Administration for a biosimilar from the 12 years provided under pending healthcare legislation, or strike the biosimilars language from the bill altogether, an organization representing the generic drug industry has called on President Barack Obama to tell Congress.

In a letter to president Obama Tuesday, Generic Pharmaceutical Association president and CEO Kathleen Jaeger asked Obama to urge Congress to lower the data exclusivity period from 12 years to one that would “ensure timely entry of safe and affordable biosimilars and biogenerics to the market.” Either that, Jaeger wrote, or do away with the biosimilars provision.

“The inclusion of the current fatally flawed language is arguably worse than the effective monopoly that the biotech industry enjoys because it represents an empty promise to Americans who may falsely believe that the legislation will provide for meaningful competition,” Jaeger wrote. “This simply will not increase access or contain drug spending costs; rather, it represents little more than camouflaged protection of the unacceptable and unsustainable status quo.”

The GPhA wants biotech drugs to have five years’ data exclusivity – as pharmaceutical drugs already do – while the biotechnology has called for up to 14 years, saying that the unique properties of biotech drugs would allow potential biosimilar manufacturers to engineer around their patents. The White House has suggested a seven-year exclusivity period.