FDA, Drugmakers Agree to Next Round of Biosimilar User Fees

Sept. 21, 2021, 8:45 PM

Drugmakers could having an easier time getting cheaper, interchangeable biological products across the finish line under a new FDA strategy to facilitate their development as part of the next user fee agreement.

The Food and Drug Administration on Tuesday released a letter outlining its commitments to industry for the next round of biosimilar user fees for fiscal years 2023 through 2027. User fees paid by drugmakers help fund FDA operations, and in exchange the agency agrees to meet certain performance goals.

The letter marks a critical step that indicates industry and the FDA have completed their negotiations—setting the stage for ...

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