Last August the US Food and Drug Administration (FDA) published draft guidelines for industry on the naming of biologics, in light of the arrival of biosimilar products on the market.
The Agency said in order to clearly identify biological products to improve pharmacovigilance, nonproprietary names will have to include a suffix composed of four unique lowercase letters “devoid of meaning.”
But in an administrative update published in the Federal Register Thursday, the FDA said the name would be chosen from up to 10 proposed suffixes submitted by the applicant in the order of preference, leading to the question of whether a product’s name will remain as random as intended.
The only biosimilar currently available in the US is Zarxio, a version of Amgen’s Neupogen approved in March 2015 before the draft guidance was published. Its non-proprietary name is filgrastim-sndz, a clear allusion to its developer Sandoz.
But the second biosimilar to be approved in the US, Pfizer/Celltrion’s Inflectra (reference product Remicade), has been designated a less meaningful name, infliximab-dyyb.
The update comes a month after the Alliance for Safe Biologics Medicines (ASBM) – an industry-patient pressure group which counts Biotechnology Industry Organisation (BIO), Genentech and Amgen among its members – called for the creation of “a system of distinguishable names for all biologic medicines, including biosimilars” in a letter sent to the Agency on behalf of a 70 group coalition of healthcare stakeholders.
FDA spokesperson Sandy Walsh could not comment on the change, saying the Agency is still working on the final biological product naming guidance.
“The FDA proposed draft guidance in August 2015 that outlined the agency’s thinking about nonproprietary naming of biological products,” Walsh told Biopharma-Reporter. “The initial public comment period closed on October 27, 2015 and the FDA is carefully considering all comments that have been submitted to the public docket as it finalizes the guidance.”