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Biosimilar User Fee Agreement Offers FDA Funding Boost, Fee Structure Overhaul

 
• By Sue Sutter

BsUFA revenue amounts and fees will be separated from PDUFA and relative contribution of each fee type to the overall pot will change; user fee revenue target for program's first year is $45m.

The changes proposed for the second iteration of the Biosimilar User Fee Act program suggest FDA and industry agree the agency needs a massive funding boost to handle an expected crush of applications and provide sponsors with timely regulatory advice on the complexities of biosimilar product development.

Under the FDA-industry negotiated BsUFA II agreement released Sept. 16, FDA's biosimilar user fee revenue will almost double over a...

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