Senate Committee Passes Follow-On Biologics Bill

June 28, 2007

Compromise legislation aimed at creating a pathway for FDA follow-on biologic product approval passed by unanimous voice vote in the Senate Health, Education, Labor and Pensions Committee. Chairman Edward Kennedy (D-Mass.) said the committee plans to attach the bill to the Prescription Drug User Fee Act (PDUFA) reauthorization bill during conference committee.

The Biologics Price Competition and Innovation Act, S. 1695, allows the FDA to use its scientific discretion in approving products that are biosimilar to existing biologics. The agency could also determine that a product is interchangeable with the innovator biologic, and the first interchangeable product to be approved would receive a year of marketing exclusivity.

However, the legislation contains several provisions that continue to concern the generic drug industry. The Generic Pharmaceutical Association opposes the 12 years of data exclusivity the bill would grant to innovators biologic drugs.

Sen. Sherrod Brown (D-Ohio) had drafted an amendment that would have shortened the exclusivity period to seven years. But the bill’s creators — Sens. Mike Enzi (R-Wyo.), Hillary Rodham Clinton (D-N.Y.) and Orrin Hatch (R-Utah), along with Kennedy — were unwilling to budge from 12 years. Brown withdrew the amendment without a vote.

The Senate passed the PDUFA bill and is awaiting the House floor vote — expected to happen in July — at which point the two chambers will meet to reconcile their versions of the legislation.