AE reporting for biologicals

Biosimilars/Research | Posted 27/11/2015 post-comment0 Post your comment

Researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1] examined primary suspect reports sent to the US Food and Drug Administration’s (FDA) 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 about how naming of biosimilars might affect the traceability of adverse events (AEs).

Pharmacovigilance V13F21

Tufts CSDD examined all primary suspect reports sent to FAERS for somatropin and human insulin from US reporters between the fourth quarter of 2005 and the third quarter of 2013. A total of 4,703 insulin reports and 6,487 somatropin reports were extracted from FAERS. These reports were stratified by whether the drug name associated with the report contained a brand name, i.e. could be found on the FDA NDC database; a name that was attributable to a brand, i.e. could be linked to a manufacturer; or an ambiguous name, i.e. could not be linked to a manufacturer. These reports were further divided by whether or not a lot (batch) number was included in the report.

For the insulin reports, 16% contained an ambiguous name, 87% of which did not report a lot number. Of all insulin reports, i.e. those not stratified by name), only 37% contained a lot number. The authors therefore concluded that Considerations for Biosimilar Naming and Reporting Practices 13.5% of the 4,703 insulin primary suspect reports were not traceable to a manufacturer or lot number.

For the somatropin reports, 8% contained an ambiguous name, 96% of which did not have an associated lot number, i.e. 7.5% of all somatropin primary reports were not traceable to a manufacturer or lot number. Of all somatropin reports, only 13% contained a lot number.

The authors concluded that reporting practices for the two biologicals are inconsistent and that identification of the manufacturer and traceability are lacking. They add that ‘current reporting practices can and must be improved’.

Recommendations made by the authors included that ‘the FDA should not only consider biosimilar nomenclature but also should consider improving the reporting of lot numbers in order to ensure traceability to a company manufacturing process’.

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 pharmacovigilance for biologicals are invited to visit to view the following manuscript published in GaBI Journal:

Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance

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

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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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