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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The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
Up to $1m per year per award is available for projects that address significant issues with biosimilar or interchangeable product development.
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.