Curious Biosimilar Issues: More Workload, But Fewer US FDA Staff Needed

The US FDA’s capacity planning formula indicates a smaller biosimilar program than a year ago, but says supplement, meeting and other work continue to increase.

Biosimilar program projections from the US Food and Drug Administration suggest fewer staff are needed than a year ago, even as several workload metrics continue to increase.

The agency’s capacity planning adjustment predictably estimated that funding for more full-time equivalent paid staff is necessary for the biosimilar...