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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Remote Inspections: Stakeholders Seek Clarity As Some At US FDA Struggle With Process
Some lawmakers want FDA to prioritize in-person visits, but others are complaining that more remote inspections are needed because approvals are being delayed.
US Biosimilar Approvals In 2021 Were Few But Included Many Firsts
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.
FDA Will Take Action On Biosimilars Delayed By Inspection Lag
With multiple US biosimilar applications held up by the FDA’s inability to conduct necessary inspections in the context of the COVID-19 pandemic, the agency tells Generics Bulletin that it is “actively working” on a solution.