FDA Publishes BsUFA III Commitment Letter Ahead Of 2022 Renewal

Biosimilar Supplement Review Goals Aim To Speed Approvals

Following months of negotiations with industry and stakeholders, the FDA has released the commitment letter for the third iteration of its five-year Biosimilar User Fee Amendments program, marking another step ahead of its reauthorization.

Entrance to FDA headquarters in Maryland
BSUFA III covers the fiscal years 2023-27 • Source: Shutterstock

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