20 October 2017 - Back in January, the US FDA finalised guidance on how biosimilars and their biologic reference products' names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

But between January and now, of the biologics and biosimilars approved, only the biosimilars' names have included the random four-letter suffixes. The discrepancy leads to questions of inequity between the two products and when, if ever, FDA will go back and start renaming biologics' nonproprietary names with the suffixes.

Hillel Cohen, executive director of scientific affairs at Novartis' Sandoz, told Focus: "No question that FDA suffixes are intended to be rolled out to all biologics, including retroactively renaming products already approved." 

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