WHO vs. FDA: How The Biologic Naming Plans Stack Up
Executive Summary
Side-by-side chart compares World Health Organization's initial published proposal with the final version and FDA's August 2015 draft guidance on nonproprietary naming of biologic products.
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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.
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.
Biological Product Suffix Submissions Limited To 10 Candidates By US FDA
Increasing cap on number suffixs that sponsors can submit from three to 10 will increase review efficiency, agency says, but evaluation will still stop after finding first acceptable suffix as part of final guidance on distinguishable nonproprietary names for novel biological products and biosimilars.