title: Statistical Primer on Biosimilar Clinical Development.
abstract: A biosimilar is highly similar to a licensed biological product and has no clinically meaningful differences between the biological product and the reference (originator) product in terms of safety, purity, and potency and is approved under specific regulatory approval processes. Because both the originator and the potential biosimilar are large and structurally complex proteins, biosimilars are not generic equivalents of the originator. Thus, the regulatory approach for a small-molecule generic is not appropriate for a potential biosimilar. As a result, different study designs and statistical approaches are used in the assessment of a potential biosimilar. This review covers concepts and terminology used in statistical analyses in the clinical development of biosimilars so that clinicians can understand how similarity is evaluated. This should allow the clinician to understand the statistical considerations in biosimilar clinical trials and make informed prescribing decisions when an approved biosimilar is available.
authors.affiliation: 1Biotechnology Clinical Development Statistics, Pfizer Inc, Cambridge, MA; and 2Global Established Pharma Medicines Development Group, Pfizer Inc, New York, NY.
authors.forename: Leah
authors.initials: L
authors.lastname: Isakov
authors.forename: Bo
authors.initials: B
authors.lastname: Jin
authors.forename: Ira Allen
authors.initials: IA
authors.lastname: Jacobs
mesh_terms: D059451:Biosimilar Pharmaceuticals; D002986:Clinical Trials as Topic; D017277:Drug Approval; D055808:Drug Discovery; D006801:Humans; D013223:Statistics as Topic; D009626:Terminology as Topic
chemical_list: D059451:Biosimilar Pharmaceuticals