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FDA Issues Guidance for Naming Biosimilars


With 1 biosimilar already approved in the US, the FDA has finally released draft guidelines for naming these new products.

After the FDA approved the first biosimilar in the US, the discussion quickly turned to the next challenge: what would be the naming procedure for these new products?

Now, the FDA has released draft guidance detailing the proposed naming of biological products. The agency has proposed that reference products and biosimilars have names that share a core drug substance and an FDA-designated suffix to better identify each product.

“There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable,” the agency wrote in draft guidance for nonproprietary naming of biological products.

Another potential naming convention that the FDA is considering is the use of a suffix derived from the name of the license holder.

The FDA is including 6 previously licensed biological products, so filgrastim-sndz would become filgrastim-bflm, filgrastim would be filgrastim-jcwp, tbo-filgrastim would be filgrastim-vkzt, pegfilgrastim would be pegfilgrastim-ljfd, epoetin alfa would be epoetin alfa-cgkn, and infliximab would be infliximab-hjmt.

The naming convention for these 6 products is being considered because the FDA believes it would help prevent inadvertent substitution and will help protect the safety of patients.

The Academy of Managed Care Pharmacy (AMCP) quickly made known its displeasure with the proposal to name biologics, including reference products and biosimilars, with a nonproprietary name with an FDA-designated suffix.

AMCP Chief Executive Officer Edith A. Rosato, RPh, IOM, said in a statement that since the current naming convention has been proven safe for biological products in Europe, it should be used in the US as well.

“AMCP is concerned that any departure from the currently accepted nonproprietary naming system will create confusion amongst healthcare practitioners and patients, have negative effects on the ability to ensure safe dispensing and tracking, and result in lower market adoption and cost-savings,” she said.

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