With the 14th round of Trans-Pacific Partnership (TTP) talks scheduled for September 6-15, 2012, in Virginia, a number of lawmakers have expressed their support to the Obama administration for the inclusion of a provision protecting the 12 years of reference product exclusivity provided under U.S. law for biological medical products. Twelve years of protection would align the pact with the Biologics Price Competition and Innovation Act of 2009, although the administration’s 2013 budget proposal apparently seeks to reduce that period to seven years.

The latest comments appear in an August 6, letter to President Barack Obama (D), from Senator Claire McCaskill (D-Mo.) who said, “Providing 12 years of exclusivity for biologics in the United States and abroad safeguards an important foundation for a vibrant U.S. biopharmaceutical industry and workforce.” Data exclusivity, said to preserve innovation incentives, is the period of time between the Food and Drug Administration’s approval of a reference product and the point at which an abbreviated filing for a biosimilar relying on the innovator’s data on safety and efficacy can receive final approval.