Biosimilar User Fee Rates for Fiscal Year 2027
Published Date: 7/30/2026
Notice
Summary
Starting October 1, 2026, companies making biosimilar drugs will pay updated fees to the FDA for developing and getting approval for their products. These fees cover new drug development, application reviews, and yearly program costs. This helps the FDA keep biosimilar drug reviews speedy and fair while supporting innovation.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
New FY2027 Biosimilar Fee Schedule
Starting October 1, 2026, companies developing biosimilar drugs must use the FY2027 FDA fee schedule through September 30, 2027. Key fees are: initial and annual BPD fee $10,000; reactivation fee $20,000; application fee requiring clinical data $1,124,936; application fee not requiring clinical data $562,468; and program fee $195,887.
Small Business Application Fee Waiver
Under certain conditions, FDA may grant a small business a waiver of the biosimilar biological product application fee (per section 744H(d)(1) of the FD&C Act). This could exempt qualifying small businesses from paying the application fee that would otherwise be $1,124,936 (with clinical data) or $562,468 (without clinical data).
Reactivation and Owed BPD Fees Requirement
If a sponsor discontinued participation in the BPD program or was administratively removed and wants to reengage, the sponsor must pay all annual BPD fees previously assessed and still owed plus a reactivation fee. The reactivation fee is $20,000 and must be paid no later than 7 calendar days after FDA grants a BPD meeting or upon submission of an IND intended to support a biosimilar application.
When Fees Are Due and How to Pay
The initial BPD fee is due when a sponsor submits an IND intended to support a biosimilar application or within 7 calendar days after FDA grants the first BPD meeting. Application fees are due upon submission. Annual BPD and program fees are due October 1, 2026, with invoices issued in August 2026. Payments can be made online via Pay.gov, ACH (eCheck) or credit card (credit card only for balances under $25,000), or by wire transfer.
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