12 January 2017 - In a departure from the way the WHO and Europe name biologics, the US FDA has finalised long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name.

The decision to finalise this guidance follows not only several tweaks (including one that has companies submit 10 suffixes to FDA for consideration as part of the naming of biologics, which is included in the final guidance) but large opposition to the idea of using meaningless rather than meaningful suffixes that could make it easier to distinguish the manufacturers of the products.

For example, the first biosimilar approved by FDA was for Sandoz’s Zarxio, which includes a non-proprietary name with a meaningful suffix (Sndz for Sandoz): filgrastim-sndz.

The FDA has said it will change Zarxio’s non-proprietary name from filgrastim-sndz to “filgrastim-bflm" and Amgen's Neupogen (filgrastim) would be changed to "filgrastim-jcwp."

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