Will FDA Add Suffixes to Approved Biologics' Names?

Regulatory NewsRegulatory News | 20 October 2017 |  By 

Back in January, the US Food and Drug Administration (FDA) finalized 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."

Cohen pointed to a proposed rule from August 2015 highlighting FDA's decision to rename several biologics, though that rule has yet to be finalized.

He added that it's "definitely a problem that originator biologics that have been approved since the guidance was issued but without suffixes."

Although some claim FDA did not want to hold up the approval of originator biologics already under review, Cohen noted, "That may have been a valid reason for products approved 1Q and perhaps even 2Q 2017. But since it has now been 10 months since naming guidance was finalized, this potential reason is no longer valid."

And have physicians' perceptions been altered and have biosimilar sales suffered due to the addition of the suffix to the nonproprietary names of biosimilars?

Cohen said it is "hard to quantify whether the inequities are already having an impact in terms of sales, but from a safety perspective, if there is a safety report from the field that only contains the core non-proprietary name, it is now being assumed that it relates to the reference product."

He also noted that the Federal Trade Commission is on the record stating that inequities in product naming may have an impact in the market.


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