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FDA Implements Long-Awaited Biological Product Naming Regulations


This past week, the FDA began the long-awaited process of adding a 4-letter suffix devoid of meaning, to the end of newly approved biologics’ nonproprietary names.

This past week, the FDA began its long-awaited process of adding a 4-letter suffix, devoid of meaning, to the end of newly approved biologics’ nonproprietary names. This move reflects a change in previous policy that only added the suffixes to biosimilars’ nonproprietary names.

The first implementation of this policy change came last Thursday with the approval of Roche’s Hemlibra (emicizumab-kxwh), which is one of the first new medicines in nearly 2 decades to treat people with hemophilia A, and was followed by the approval of Ultragenyx Pharmaceutical’s Mepsevii (vestronidase alfa-vjbk), which treats pediatric and adult patients with the rare genetic condition mucopolysaccharidosis type VII.

This policy and name change has been expected since January 2017, when the FDA announced finalized guidelines that biosimilars’ and biologics’ names should include these 4-letter, non-meaningful suffixes.

However, this change has not been entirely popular amongs healthcare stakeholders. Last year, 70 groups of non-profits and other stakeholders, headed by the Alliance for Safe Biologics, requested in a letter that the FDA use meaningful suffixes for biosimilar nonproprietary names, as they did with the first biosimilar approval of Zarxio (filgrastim-sndz). The group stated that meaningful suffixes were more desirable than the random suffixes that were described in the FDA’s guidance. The Alliance for Safe Biologics has also stated that a survey of 401 US pharmacists showed that 77% preferred manufacturer-based suffixes over options without meaning.

There have also been concerns that the use of this new naming system for biologics and biosimilars could lead to confusion when implementing pharmacovigilance. A research article published in eLife found that approximately 1% of entries in the FDA’s Adverse Event Reporting System (FAERS) database represent redundant reports. This is a serious concern because duplicate reports can increase the alleged significance of an adverse event (AE) association with a drug. The study goes on to question whether tracking fewer names for drugs, rather than more, could lead to improved pharmacovigilance, especially when considering that AE’s are predominantly reported by nonmedical persons.

The World Health Organization (WHO) had proposed a similar change to that made by the FDA. They were considering the use of biological qualifiers (BQ) to assign international nonproprietary names to biosimilars. Since this proposal was made, however, the WHO has announced that, for the time being, it will not proceed with this change. In response to this news, The Biosimilars Council praised WHO on twitter, saying that the use of an added BQ for biosimilar drugs would act as an additional barrier to patient access and savings.

Despite dissent of the need for suffixes, the FDA remains firm in its belief that the designations are necessary. “Nonproprietary names that include distinguishing suffixes can serve as a key element to identify a specific product in spontaneous adverse event reporting…other product-specific identifiers, such as proprietary names or NDCs, may not be available or change over time,” said the FDA in its guidance.

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