Governors urge preservation of current biosimilars legislation
WASHINGTON Six governors are hoping to thwart an attempt by the Obama administration to eliminate language in the healthcare-reform bill that would give biotech drugs 12 years of exclusivity before facing competition from biosimilars, according to published reports.
In a letter to Barack Obama Tuesday, the governors — Martin O’Malley of Maryland, Bill Ritter of Colorado, Jack Markell of Delaware, Deval Patrick of Massachusetts and Beverly Perdue of North Carolina, all Democrats, and Republican Donald Carcieri of Rhode Island — urged Obama to keep the existing language.
The existing language would require the Food and Drug Administration to wait 12 to 14 years before it could use an innovator company’s clinical trial data to approve a biosimilar, also known as the data exclusivity period. Obama, several members of Congress, the generic drug industry and others have pushed for much shorter data exclusivity periods, ranging from five to seven years.