US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times
An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.
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Some lawmakers want FDA to prioritize in-person visits, but others are complaining that more remote inspections are needed because approvals are being delayed.
While US biosimilar approvals have been somewhat thin on the ground in 2021 – with the pandemic driving inspection-related delays for multiple products – there were nevertheless several firsts this year, including the first two interchangeables and the first ophthalmic biosimilar.
Only about one-third of biosimilars received a first-cycle approval from US FDA after product quality discussions during the mid-assessment-cycle meeting, according to an interim report on the biosimilar application review program.