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

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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