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FDA Will Take Action On Biosimilars Delayed By Inspection Lag

US Agency Says It Is ‘Actively Working’ On Addressing Outstanding Inspections

 
• By Dave Wallace

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.

COVID-19 coronavirus tape barrier
The pandemic has acted as a barrier to FDA inspections • Source: Alamy

The US Food and Drug Administration is “actively working” on addressing barriers to inspections caused by the COVID-19 pandemic that have resulted in delays to agency action on products including multiple biosimilars, the regulator has told Generics Bulletin.

Late last year, Viatris and Biocon saw their application for a biosimilar version of Avastin (bevacizumab) knocked back by the FDA, explaining that “due to restrictions on travel related to COVID-19, the agency is unable to conduct an inspection during the current review cycle

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