BsUFA Revenue Missed Estimates Again In FY2019
Spending Reduced To Account For Shortfall
US FDA said that total BsUFA obligations also decreased compared to estimates, but maintains optimism about future revenue increases.
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The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.
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.
The agency hopes application volume increases, but warns the biosimilar user fee revenue will remain volatile.