Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting

Danijela Stojanovic, Lisa Wolf, M. Stacey Ricci, Monica A. Muñoz · 2026

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Description

Danijela Stojanovic, Lisa Wolf, Stacey Ricci, and Monica Muñoz check whether safety reports name copycat biologic drugs precisely, in a 2026 study. United States rules give each such drug a four-letter suffix so reports can tell makers apart.

The team read 24,711 reports covering all 72 approved biosimilars in the federal safety database through August 2025. Only about 13 percent used the suffix, while 98 percent used the brand name and 82 percent named the maker. The suffix stood alone in under 2 percent of reports. Those reports came mostly straight from professionals and veterans' hospitals, and they described more serious outcomes. Weak naming, the authors warn, blurs safety tracking for these drugs.

Catalog record

CREATORDanijela Stojanovic, Lisa Wolf, M. Stacey Ricci, Monica A. Muñoz
YEAR2026
COLLECTIONPAPERS
FORMATTXT
FILE SIZE31 KB
VERSION1.0
LICENSECC BY 4.0
RIGHTSCC BY
SOURCEEurope PMC

Source: https://europepmc.org/articles/PMC13547537

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