BsUFA III Negotiations Nearly Done; Commitment Letter Being Written
Supplement approval timeline and regulatory science issues apparently have been resolved.
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Alvotech Adalimumab Biosimilar Switching Study Hits Key Date
Alvotech underlined that it could “save US consumers and taxpayers billions annually,” after hitting a key landmark in its Phase III switching study for its high concentration 100mg/ml biosimilar Humira product.
CBER, ORA Saw FY 2020 User Fee Spending Drop Even As COVID Strained US FDA’s Resources
ORA continued to spend user fee dollars despite its inability to travel for facility inspections, while CBER found little generic and biosimilar work during FY 2020.
Pandemic Effect: Sponsors Paid Far Fewer User Fees Than Expected In FY 2020
Revenue increases are expected in FY 2021 over pre-pandemic estimates, in part because the US FDA believes sponsors may have applications that were delayed by COVID-19.