title: Similar names for similar biologics.
abstract: Approval of the first biosimilar in the USA may occur by the end of 2014, yet a naming approach for biosimilars has not been determined. Biosimilars are highly similar to their biologic reference product but are not identical to it, because of their structural complexity and variations in manufacturing processes among companies. There is a need for a naming approach that can distinguish a biosimilar from its reference product and other biosimilars and ensure accurate tracing of adverse events (AEs) to the administered product. In contrast, generic small-molecule drugs are identical to their reference product and, therefore, share the same nonproprietary name. Clinical trials required to demonstrate biosimilarity for approval may not detect rare AEs or those occurring after prolonged use, and the incidence of such events may differ between a biosimilar and its reference product. The need for precise biologic identification is further underscored by the possibility of biosimilar interchangeability, a US designation that will allow substitution without prescriber intervention. For several biologics, the US Food and Drug Administration (FDA) has used a naming approach that adds a prefix to a common root nonproprietary name, enabling healthcare providers to distinguish between products, avoid medication errors, and facilitate pharmacovigilance. We recommend that the FDA implement a biosimilars naming policy that likewise would add a distinguishable prefix or suffix to the root nonproprietary name of the reference product. This approach would ensure that a biosimilar could be distinguished from its reference product and other biosimilars in patient records and pharmacovigilance databases/reports, facilitating accurate attribution of AEs.
authors.affiliation: Hôpital Saint Antoine, Paris, France.
authors.forename: Nicole
authors.initials: N
authors.lastname: Casadevall
authors.forename: Thomas
authors.initials: T
authors.lastname: Felix
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Strober
authors.forename: David G
authors.initials: DG
authors.lastname: Warnock
mesh_terms: D059451:Biosimilar Pharmaceuticals; D017277:Drug Approval / Q000458:organization & administration*; D057915:Drug Substitution; D006801:Humans; D060735:Pharmacovigilance; D009626:Terminology as Topic; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration* / Q000592:standards
chemical_list: D059451:Biosimilar Pharmaceuticals