Batch and Lot Information Would Improve Biosimilar Pharmacovigilance, Report Argues

Pharmacovigilance is important for any new drug, but it is especially key in tracking the safety of biologics in the era of biosimilar market entry. A paper recently published in the Journal of Managed Care & Specialty Pharmacy argues that the addition of a single data element—namely, a batch or lot number—would enhance the value of pharmacovigilance systems.

In the paper, Sreedhar Sagi, PhD; Hillel P. Cohen, PhD; and Gillian R. Woollett, MA, DPhil, explain that they sought to identify the most effective data element by which to immediately attribute an adverse event to a specific medicine, and found that, while current pharmacovigilance systems are adequate, adding more data could prove useful.

The authors examined records from the Sandoz post-marketing safety databases representative of approximately 350 million patient days of treatment with Sandoz-sponsored biosimilars to somatropin, epoetin alfa, and filgrastim. Because multiple product names were used for the same products in different markets, the results, collected in a single database, allowed for insight into pharmacovigilance capabilities for dealing with multiple names for a given therapy. They also investigated periodic safety update reports and supplemented their data with information available on biologics from the Danish Medicines Agency.

While some have suggested that brand names are not sufficient for biologic and biosimilar pharmacovigilance, the authors report that spontaneous adverse drug reaction reports are made with the use of the brand name in the majority of cases, and that there is no evidence that the nonproprietary name is a common identifier (nor is there evidence that it is a source of confusion). In the case of epoetin alfa, 355 reports were identified. Only 8 reports did not identify a specific brand. Somatropin generated 1603 reports, among which the brands of 35 were unknown. Finally, filgrastim was responsible for 533 reports, among which 36 did not specify a brand.

However, inclusion of batch and lot records would allow any issue related to specific batches or lots of a product to be captured swiftly. The authors suggest that these data points could be recorded by either healthcare providers or pharmacists, and that a barcode system, such as the one implemented in the European Union, would facilitate real-time recording. The United States, the authors note, is developing a legislatively mandated initiative to use a standardized numerical identifier to record product information.

Whatever the methodology, inclusion of batch/lot information should allow for the grouping of medicines by shared attributes (such as active pharmaceutical ingredient), brand name or manufacturer and nonproprietary name, and specific batches and lots of an individual medicine. These 3 attributes, the authors say, “allow maximal pooling of data in a manner that can lead to more timely decisions.”