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

 
• By Sue Sutter

A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.

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US FDA's plan for spending down its biosimilar user fee carryover balance unexpectedly accelerated in FY 2018, forcing the agency to readjust. • Source: Shutterstock

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...

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