Nomenclature and Traceability Debate for Biosimilars: Small-Molecule Surrogates Lend Support for Distinguishable Nonproprietary Names

Conclusion Use of the same nonproprietary name for generic and branded products may contribute to poor traceability of AEs reported in the FAERS database due to the significant misattribution of AEs to branded products (when those AEs were in fact associated with patient use of generic products). To ensure accurate and robust safety surveillance and traceability for biosimilar products in the United States, improved product identification mechanisms, such as related but distinguishable nonproprietary names for biosimilars and reference biologics, should be considered.
Source: Advances in Therapy - Category: Drugs & Pharmacology Source Type: research