Comparing safety information of biosimilars with their originators: a cross-sectional analysis of European risk management plans.
Leroy R A LepelaarsFrancesca RendaLuca PaniGiuseppe PimpinellaHubert G M LeufkensGianluca TrifiròGiovanni TafuriAukje K Mantel-TeeuwisseFrancesco TrottaPublished in: British journal of clinical pharmacology (2018)
Based on publicly available information filed for regulatory purposes, no substantial differences were observed in the reporting of safety information for biosimilars and related originators. A direct comparison between biosimilars and related originators through formal postmarketing studies is needed to evaluate specific safety issues emerging during the products' life cycle.