The US Food and Drug Administration’s biosimilar approvals appear to be the agency operation that is suffering the most under the strain of the coronavirus pandemic, but the FDA argues the drop in on-time actions is a function of the program’s relatively small sample size, not an inherent performance problem.
US FDA's On-Time Review Decision Rates Slip During The Pandemic, Especially For Biosimilars
Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.
