FDA draft guidance proposes use of suffixes for biosimilars

The FDA on Thursday released draft guidance proposing that biosimilar medicines in the US are distinguished from their brand-name counterparts by attaching a suffix to their generic name. The agency stated that the proposal would help pharmacists to avoid inadvertently substituting one drug for another when the regulator has determined that the therapies are not interchangeable. The FDA added that it hasn’t yet decided whether biosimilars that are considered interchangeable would require a unique suffix or share the same as the branded version.

Specifically, the regulator proposed that both the reference product and biosimilar be given a four-letter suffix that is unique to each. The FDA noted that the suffix chosen will not have any special meaning. The agency suggested that its proposal could facilitate safety monitoring of all biological products after they reach the market by allowing individual products to be tracked at all levels of care, such as outpatient, hospital and pharmacy settings.

The FDA remarked that it is also considering procedures to best implement this proposal for previously approval biologics. As such, the regulator has also proposed a rule in which previously licensed biological products would be given a non-proprietary name featuring a suffix.

Earlier this year, Novartis' Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen (filgrastim), became the first biosimilar to receive approval from the FDA. Under the new guidelines, Neupogen would be called filgrastim-jcwp, while Novartis' version would be dubbed filgrastim-bflm.

The agency added that other drugs affected are either a reference product for an approved or publicly disclosed biosimilar product application or a biological product that is either biosimilar to or related to one of these reference products. As such, Teva's version of Neupogen would be named filgrastim-vkzt, while Amgen’s Epogen and Johnson & Johnson’s Remicade would be called epoetin alfa-cgkn and infliximab-hjmt, respectively.

Celltrion submitted Remsima, a biosimilar of Remicade, for FDA approval in 2014, although the agency postponed an advisory panel meeting for the drug in February. For related analysis of the biosimilars market, see ViewPoints: Have biosimilar players won the patent-dance off? and ViewPoints: Do expectations need to be reset for biosimilar pricing?.

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