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Biosimilar User Fee Forecast: Unchanged Or Lower In FY 2019, US FDA Says

 
• By Sue Sutter

Absence of any fee increases reflects growing numbers of both approved biosimilars and products under development, as well as agency’s commitment to start spending down some of the carryover balance from prior years’ fee collections.

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Biosimilar product developers will find good news in the US FDA user fee rates for the coming fiscal year, with product development fees declining and the levies for applications and approved products remaining unchanged.

The absence of any fee increases in fiscal year 2019 reflects a combination of factors, including growing numbers of both approved products and participants in the agency’s Biosimilar Biological Product...

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