FDA’s biosimilar program is expected to be starved for funding in its early years, although that is partially by design.
Biosimilar user fee revenue is not likely to be robust during the first few years because establishment, product and other...
Biosimilars Program Will Be “Under-Resourced” In Early Years As Industry Grows
CDER Director Janet Woodcock says user fee revenue will increase slowly, in part because some fees will not produce much revenue until the biosimilar industry expands.
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