While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.
The U.S. biosimilar market is coming of age under the BsUFA II agreement, but there are a few steps the FDA could take to help it develop more predictably. For starters, the agency should conduct pre-approval inspections earlier in the 12-month biosimilar review cycle to give sponsors time to address unexpected issues, industry representatives told the FDA Jan. 27 in response to an independent interim assessment of the enhanced transparency and communication processes included in the current user fee agreement.
If the FDA’s opening meeting Nov. 19 on the reauthorization of BsUFA is anything to go by, interchangeability could be a key part of the next round of U.S. biosimilar user fee negotiations.
