Biosimilar User Fee Forecast: Unchanged Or Lower In FY 2019, US FDA Says
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.
You may also be interested in...
FDA's predictions have been pretty consistent; actual submissions haven't been.
Agency is meeting its review timelines for biosimilar applications but handing our more complete response letters than first-cycle approvals; sponsors have publicly disclosed 24 original biosimilar application submissions to the agency since the review program began in fiscal year 2013, with 10 product approvals to date and at least 13 CRLs, according to the Pink Sheet's biosimilars report card.
Agency will substantially reduce amount of human drug and biosimilar user fees that it carries over from year to year by the end of fiscal 2022; carryover generic drug and biosimilar fees will go toward hiring term-limited employees and building capacity, but a technical issue will keep FDA from accessing $79m in PDUFA fees.