Biologics Naming: US FDA Ponders How To Put New System In Place, While WHO Puts Hold On Pilot Study
US regulator is currently focused on prospective application of suffix-based naming system for most novel biologics and biosimilars but is still considering how best to change the names of existing products. Meanwhile, World Health Organizations announces it will not proceed 'at present' with its biological qualifier program.
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FDA has cleared four novel biologics without a suffix despite finalizing nonproprietary naming guidance; the agency requests sponsors submit proposed suffixes at the time a BLA is submitted.
Costs across the US healthcare system of implementing new suffix-based nomenclature could reach into the billions, stakeholders say in requesting the Office of Management and Budget delay implementation of FDA’s final guidance on nonproprietary naming of biologics pending further analysis.
Biosimilar applications using the 351(k) pathway under review at US FDA. Updated upon new submissions.