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Regulation Biosimilars FDA

US Biosimilar Fee Collections Fall Short

The FDA Has Modified Its Carryover Spend-Down Plan

  • Analysis

Executive Summary

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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