Biosimilar User Fee Agreement Reached, But Will Require Appropriations Boost
This article was originally published in The Pink Sheet Daily
Tentative agreement closely resembles FDA's original proposal.
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Mid-December kick-off meeting puts emerging user fee program on much later track than others.
Absent guidance, the company says it is submitting proposals for trial designs it believes could demonstrate biosimilar interchangeability.
FDA and advocates wait for OMB to clarify how the estimated 7.8% budget cut should be implemented, if it is enacted. Former agency officials say it could lead to hiring freezes and program delays.