US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement
Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.
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Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
US FDA Making BsUFA III Regulatory Science Grants Available Early
Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.
FDA Official Foresees Reduced Biosimilar Data Burden
New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.