It looks like the FDA will keep the suffix for nonproprietary, or "proper," names for biologics – both innovators and biosimilars. But instead of the alphabet soup it first proposed, the agency may let sponsors choose their own lower-case, four-letter suffix that would be added to the biologic's core name.

The agency tipped its hand in a proposed information collection request it submitted to the White House Office of Management and Budget (OMB). It is now seeking comments on that collection, according to a notice slated for publication in Thursday's Federal Register.

Under the proposal, the FDA would ask sponsors to submit up to 10 possible suffixes, in the order of their preference. Sponsors also may be asked to provide supporting analyses to show that each proposed suffix meets the factors described in the agency's guidance. The FDA anticipates it will receive 40 requests each year for proposed proper names for drugs approved as new biologics and six requests for biosimilars and interchangeable products.

"There is a need to clearly identify biological products to facilitate pharmacovigilance and, for the purposes of safe use, to minimize inadvertent substitution," the FDA said in the notice as justification for the suffixes.

The change in direction from the random, meaningless suffixes the agency first proposed comes in response to comments on the draft naming guidance the FDA released last year. Most of the comments on that draft supported the use of a suffix in proper names, with many urging the use of a meaningful, distinguishable suffix to "improve pharmacovigilance, enhance safety and facilitate identification between biological products," the FDA said. (See BioWorld Today, Aug. 28, 2015.)

Those supporting the alphabet soup approach wanted to avoid giving what they feared would be an unfair advantage to some biologics manufacturers, the FDA said in the Federal Register notice.

Although the naming guidance has yet to be finalized, the agency already has assigned suffixes to the two biosimilars it has approved – Sandoz Inc.'s Zarxio and Pfizer Inc.'s Inflectra. Since Zarxio, a biosimilar to Amgen Inc.'s Neupogen, was approved months before the draft naming guidance was released, the agency gave it a "placeholder" proper name that included a suffix based on the sponsor name – filgrastim-sndz. (See BioWorld Today, March 9, 2015.)

The FDA suggested changing Zarxio's suffix to the meaningless "bflm" in a proposed rule it floated when it released the draft naming guidance last August. The rule also included new proper names, complete with random suffixes, for biologics likely to face biosimilar competition in the near future – Remicade (infliximab, Janssen Biotech Inc.) and Amgen's Neupogen, Neulasta (pegfilgrastim) and Epogen (epoetin alfa).

The rule also would have changed the proper name for Teva Pharmaceutical Industries Ltd.'s Granix from tbo-filgrastim to filgrastim-vkzt. (Although a follow-on to Neupogen, Teva opted to develop Granix as a new biologic before the U.S. biosimilar path was fully formed.)

The suffixes proposed in the rule were never assigned, which means Inflectra is the only biologic on the U.S. market with a random suffix, infliximab-dyyb. Approved two months ago, the biosimilar was developed by Celltrion Inc. and references Remicade. (See BioWorld Today, April 6, 2016.)

Final guidance on biologic naming could still be a ways off, and the FDA will have to work through a number of issues yet. For instance, it has to figure out how to apply a new naming scheme retroactively to biologics already on the market. It also has to integrate the name changes into its transitioning of older biologics, such as insulin and hormone products, that were approved under the Federal Food, Drug and Cosmetics Act to the Public Health Services Act. And it may have to decide if Inflectra should get a suffix more to the liking of its sponsor.

In the meantime, the agency will take comments on its OMB information request through July 2, with a focus on the sponsor time involved in submitting proposed suffixes. The FDA figures it would take an average of 420 hours to provide up to 10 suffixes with justification for each.