Agency recommends statutory language for imposing user fees on biosimilar drug manufacturers.
Biosimilars are drugs that aim to replicate an already-approved biologic drug. The FDA plans on using the collected fees to fund timely review of biosimilar and related drug applications.
The FDA recommends legislation, a proposed Biosimilars User Fee Act of 2012, that would authorize HHS to assess an initial product development fee on biosimilar manufacturers that request meetings with the FDA or submit a new product protocol.
After paying the initial fee, manufacturers would also need to pay an annual product development fee. The FDA would not respond to manufacturers who have failed to pay their required fees.
The proposed statute would prevent HHS from charging biosimilar manufacturers more than the total costs of resources it allocates to biosimilar-related review activities.
The legislation also would require HHS to submit annual reports on the performance of this user fee program to relevant committees in the Senate and the House of Representatives. By 2015, HHS would also need to submit an independently contracted study on workload volume and biosimilar review costs.