FDA Biosimilar Policy Continues To Evolve With Approval Of Sandoz Erelzi
Third biosimilar approved in US brings another iteration of FDA thinking on labeling and naming; etanercept-szzs, which references Amgen's Enbrel, suggests agency might be backtracking on its suffix policy.
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Brand and generic industries are on opposite sides of spectrum on most issues; there is mutual opposition, however, to the use of a meaningless four-letter suffix in the proper name of a product.
FDA panelists' confusion over biosimilarity and overwhelming approval endorsements following glowing agency reviews suggest the meetings may not be having much impact on FDA deliberations; however, agency sees an opportunity to learn from what its external experts don't understand about biosimilars.
Drug Review Profile: Inflectra sponsor submitted nonproprietary name suffixes that were both devoid of meaning and meaningful; agency concluded nonmeaningful suffix "-dyyb" was unlikely to be source of error.