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Sandoz Tested Erelzi’s Suffix On Multiple Fronts

Executive Summary

Evaluations of potential nonproprietary name suffixes for the US biosimilar to Amgen’s Enbrel included checks on Internet search engines and databases of abbreviations and proprietary names, as well as safety, trademark and phonetic analyses.

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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.

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