Biosimilar naming and AE reporting

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Biosimilar naming and AE reporting

Biosimilares/Investigación | Posted 30/10/2015 0 Post your comment

How will biosimilar naming affect the ability to attribute adverse events (AEs) to a particular product? This is a question researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1].

A recent survey conducted by Xcenda indicated that in the US, pharmacists currently identify biologicals by the national drug code (NDC) number. This option could be viable; however, the US Food and Drug Administration (FDA) does not require that NDC numbers appear on all drug labels.

The authors suggest that there are five options for naming biologicals, including biosimilars. One option, consistent with the naming of the first FDA approved biosimilar, involves a hybrid of the International Nonproprietary Names (INN) and the manufacturer name. Another option is to adopt the World Health Organization’s new policy. A third option may involve the creation of a unique naming system, possibly similar to that endorsed by Japan’s regulatory agency. A fourth option is to use the brand name of the drug. A fifth option is to use the same INN once comparability and interchangeability have been demonstrated.

In the Tufts CSDD study Stella Stergiopoulos and co-author Kenneth Getz examined primary suspect reports sent to the FDA’s Adverse Event Reporting System (FAERS) from US reporters for two biologicals that have lost patent exclusivity somatropin and human insulin. The study was carried out to inform both FDA and the global drug development community.

A total of 4,703 insulin reports and 6,487 somatropin reports were extracted from FAERS, of which the authors claim that 13.5% and 13%, respectively, were not traceable to a manufacturer or lot (batch) number. The authors conclude that the results showed that reporting practices for the two biologicals are inconsistent and that identification of the manufacturer and traceability are lacking.

In the following series of three articles the issues related to naming and interchangeability of biosimilars and how this might affect reporting of AEs are presented.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Editor’s comment
Readers interested to learn more about naming of biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Product naming, pricing, and market uptake of biosimilars

If you are interested in contributing a research article in a similar area to the GaBI Journal, please send us your submission here.

Related articles
AE reporting for biologicals

Biosimilars and interchangeability

Reference
1. Stergiopoulos S, Getz K. Evaluating AE reporting of two off-patent biologics to inform future biosimilar naming and reporting practices. Drug Saf. 2015;38(8):687-92.

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