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# FDA Announces FY 2019 Biosimilar User Fees
- URL: https://www.fdaweb.com/fda-announces-fy-2019-biosimilar-user-fees/
- Published: 2018-07-30T12:00:00.000Z
- Updated: 2026-09-15T00:22:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141985

The initial and annual biologic product development fee for FY 2019 under the Biosimilar User Fee Amendments of 2017 will be $189,405, according to a fee schedule released by FDA. A *Federal Register* [notice](https://www.federalregister.gov/documents/2018/07/31/2018-16312/biosimilar-user-fee-rates-for-fiscal-year-2019?ref=fdaweb.com) to be published 7/31 also lists the reactivation fee as $370,818, for an application requiring clinical data $1,746,745, for an application not requiring clinical data $873,373, and for the program fee $304,162\. The fees take effect 10/1 and remain in effect through 9/30/19\. FDA says the new fees must be used for applications submitted on or after 10/1\. The report says the agency’s base revenue amount for FY 2019 is $40,214,000 before adjustments for inflation and operating reserves.