FDA opts for four-letter suffix to distinguish biologics and biosimilars

By Dan Stanton contact

- Last updated on GMT

FDA is calling on commenst for the next 60 days on its drft biological product naming guidance
FDA is calling on commenst for the next 60 days on its drft biological product naming guidance

Related tags: Food and drug administration

The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.

As the US gets set for its first ever biosimilar product – Sandoz’s Zarxio​ - next month, the US Food and Drug Administration (FDA) has laid down guidelines​ for the naming of such drugs, proposing a random four letter suffix be designated to all non-proprietary biological product names.

This would mean Amgen’s reference product Neupogen, for example, would be known in its license as ‘filgrastim-jcwp’ while the recently licensed copycat version Zarxio would be named ‘filgrastim-sndz,’ according to the proposed ruling​. Teva’s Granix, approved but not through a biosimilar pathway, would also have its license name changed from ‘tbo-filgastrim’ to filgastrim-vkzt.’

“By differentiating among biological products that have not been determined to be interchangeable, the goal of this naming convention is to help minimize inadvertent substitution [which] may lead to unintended alternating or switching of biological products,”​ the FDA said.

“This naming convention may also facilitate pharmacovigilance for multiple biological products containing related drug substances when other means to track a specific dispensed product are not readily accessible.”

Applause and apprehension

Since the implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI), industry has looked to the FDA to lay down guidelines on the naming of biosimilars, with reference drugmakers – including AbbVie, Genentech​ and J&J’s Janssen​ – petitioning the Agency to differentiate biosimilars from their original products.

The draft guidance strikes a blow to biosimilar makers, a number of which - Hospira​ and Novartis​, for example - have urged the Agency to give the same non-proprietary names in order to avoid either undermining biosimilar products or creating unnecessary confusion.

A spokesperson for biosimilar developer Pfenex told Biopharma-Reporter “the suffix will needlessly complicate the prescribing system” ​and such additional bureaucracy will inhibit biosimilars uptake, creating roadblocks to the cost savings biosimilars provide to patients and payers.”

Meanwhile, the Biologics Prescribers Collaborative (BPC) – an organisation of groups representing physicians who prescribe biologics, with no industry ties – applauded the FDA on its guidance and told us it believes “distinguishable naming will help enhance physician acceptance and use.”

Similarly, the PBSA, a patient coalition group supported by several biopharma firms including AbbVie, Baxter and CSL Behring, welcomed the guidelines:

“Unique distinguishable names for all biological medications are needed to ensure accurate tracking of medication utilization and adverse events, reduce patient and physician confusion and to enable a transparent system,”​ the group said in a statement.

Reference product name changes

Under the proposed system, three reference products, on top of Neupogen, will be renamed due to having had biosimilar applications publicly disclosed:

Amgen’s Epogen will have its non-proprietary name changed from ‘epoetin alfa’ to ‘epoetin alfa-cgkn.’

Janssen’s Remicade will have its non-proprietary name changed from ‘infliximab’ to ‘infliximab-hjmt.’

Amgen’s Neulasta will have its non-proprietary name changed from ‘pegfilgrastim’ to ‘pegfilgrastim - ljfd.’

Related topics: Markets & Regulations, Biosimilars

Related news

Show more

Follow us

Products

View more

Webinars