After Biosimilar Fee Collections Fall Short, US FDA Modifies Carryover Spend-Down Plan

The US Food and Drug Administration’s spend-down of its biosimilar user fee carryover balance is happening faster than expected, forcing the agency to readjust its five-year plan for reducing the program’s operating reserve.

A lower-than-expected number of biosimilar application submissions in fiscal year 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance to fund BsUFA operations, according to agency financial reports