title: On safety margin for drug interchangeability.
abstract: As more and more generic (or biosimilar) drug products become available in the market place, it is a concern whether the approved generic (or biosimilar) drug products are safe and efficacious and hence can be used interchangeably. According to current regulation, most regulatory agencies such as the United States Food and Drug Administration (FDA) indicate an approved generic (or biosimilar) drug product can serve as a substitute for the innovative drug product. Bioequivalence (biosimilarity) assessment for regulatory approval among generic copies (or biosimilars) of the innovative drug product are not required. In practice, approved generic (or biosimilar) drugs are commonly used interchangeably without any mechanism of safety monitoring. In this article, current bioequivalence (or biosimilarity) limit is adjusted according to the observed geometric mean ratio and corresponding variability for development of safety margins for monitoring of drug interchangeability by minimizing the relative change in response with and without the switching.
authors.affiliation: a Department of Biostatistics and Bioinformatics , Duke University , Durham , North Carolina , USA.
authors.forename: Jiayin
authors.initials: J
authors.lastname: Zheng
authors.affiliation: a Department of Biostatistics and Bioinformatics , Duke University , Durham , North Carolina , USA.
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
authors.affiliation: b Center for Food and Drug Inspection, CFDA , Beijing , China.
authors.forename: Fuyu
authors.initials: F
authors.lastname: Song
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D017277:Drug Approval; D016568:Drugs, Generic / Q000592:standards*; D006801:Humans; D013223:Statistics as Topic; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic
keywords: Alternation; drug prescribability; drug switchability; meta-analysis; switching