FDA Proposes Rule to Change Names of Zarxio, Neupogen, Four Other Biologicals

Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily.

The proposed rule affecting Neupogen, Zarxio and four other biological products was published in the Federal Register last week, alongside the agency’s much-anticipated draft guidance on biological product naming. In both cases, the naming system attaches a nonidentifiable four-letter suffix to the biological product’s official nonproprietary name.

Under the proposed rule, Neupogen’s proper name, filgrastim, would add the suffix jcwp to become filgrastim-jcwp. Zarxio, which had been given the placeholder name filgrastim-sndz, a suffix that could identify Sandoz, would become filgrastim-bflm.

The other four biological products are Sicor Biotech UAB’s Granix, which would change from tbo-filgrastim to filgrastim-vkzt; Janssen Biotech’s Remicade (infliximab), which would become  infliximab-hjmt; Amgen’s Epogen and Procrit (epoetin alfa), which would be epoetin alfa-cgkn; and Amgen’s Neulasta (pegfilgrastim), which would be pegfilgrastim-ljfd.

The rush to assign names for the six products ahead of final guidance on biologicals naming was prompted by the need to better detect product-specific safety signals and class effects, as well as to distinguish between reference, biosimilar and related biological products, the FDA says.   

The proposed names could change depending on the outcome of the final guidance on naming. The agency says it is considering several citizen petitions on the naming convention and is seeking comment on whether alternative approaches, such as suffixes derived from the name of the license holder — as in filgrastim.sndz — would be a better fit.

To minimize manufacturing or distribution disruptions, the FDA would allow drugmakers to implement new labeling reflecting the name change at the time of the next manufacturing run and to use up existing inventories of their products.

Sandoz says it will go forward with marketing Zarxio on Sept. 2 and wait for final guidance from the FDA regarding the naming process after the comment period closes.

Comments on the proposed rule are due Nov. 11. Read it here www.fdanews.com/08-28-15-proposedrule.pdf. — John Bechtel