Proposed Rule Would Change Names of Six Biologicals, Including Neupogen
Just days before Sandoz launched Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the U.S. Food and Drug Administration 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and four other biological products was published in Aug. 28’s Federal Register, alongside the agency’s much-anticipated draft guidance on biological product naming.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 (see related story).
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 is marketing filgrastim-sndz under the Zarxio name pending final guidance from the FDA regarding the naming process.
Comments on the proposed rule are due Nov. 11. Read it here www.fdanews.com/08-28-15-proposedrule.pdf. — John Bechtel
Subscribe to International Pharmaceutical Regulatory Monitor and save $200 off the regular one-year price of $895 – plus receive a FREE copy of our book FDAnews Guide to International Pharma Regulation: 2015 Edition – a $387 Value!
LINKS TO KEY DOCUMENTS — Each issue provides English-language texts of important, hard to obtain proposals, regulations, guidelines and other documents.
FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.
ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.
Copyright ©2018. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing