Novel Biologics In US Might Not Start Getting Suffixes Until August
Executive Summary
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.
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First Three Novel Biologic Suffixes Came Courtesy Of US FDA, Not Sponsors
FDA assigned a four-letter nonproprietary name suffix to Genentech's Hemlibra because an expedited review left little time to evaluate the sponsor's late-submitted proposals; UltraGenyx asked FDA to assign one for Mepsevii, while Spark submitted 10 suffix candidates for Luxturna only to see all of them rejected for being too meaningful.
First Three Novel Biologic Suffixes Came Courtesy Of US FDA, Not Sponsors
FDA assigned a four-letter nonproprietary name suffix to Genentech's Hemlibra because an expedited review left little time to evaluate the sponsor's late-submitted proposals; UltraGenyx asked FDA to assign one for Mepsevii, while Spark submitted 10 suffix candidates for Luxturna only to see all of them rejected for being too meaningful.