Biosimilar Developers Face FDA's 2026 Fee Hike
Published Date: 7/30/2025
Notice
Summary
The FDA is setting new fees for companies working on biosimilar drugs in fiscal year 2026. If you’re developing or getting approval for these drugs, expect some updated costs starting October 1, 2025. These fees help the FDA keep reviews speedy and safe, so everyone wins!
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
New Biosimilar User Fees for FY2026
If you run a company developing or seeking approval for biosimilar drugs, expect updated FDA user fees starting October 1, 2025. The fees cover initial and annual biosimilar biological product development (BPD) fees, a reactivation fee, and biosimilar biological product application and program fees for fiscal year 2026.
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