FDA is proposing to Congress that the initial and annual user fee for biosimilar products in development would be equal to 10% of the fee established for a human drug application under the Prescription Drug User Fee Act (PDUFA) for that fiscal year.
The sponsor would pay biosimilar product development fees each year until a marketing application for the product is accepted for filing or the sponsor discontinues participation in the biosimilar product development program.
Under the agency proposal, the biosimilar marketing application fee would equal the fee established for a drug application under PDUFA, minus the cumulative amount of any product development fees paid.
CDER Director Janet Woodcock commented on the proposed fee structure for biosimilars in her prepared testimony at a February 9 hearing on generic drug and biosimilar user fees and drug shortages convened by the House Energy and Commerce Committee’s Health Subcommittee.
Woodcock explained that establishment and product fees being proposed for biosimilars would, in turn, equal those established under PDUFA for a particular fiscal year, “because the level of effort required for FDA oversight of manufacturing and post-marketing safety activities is expected to be comparable for biosimilars and biological products under PDUFA.”
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