Statistical Primer on Biosimilar Clinical Development

American Journal of Therapeutics
Leah IsakovIra Jacobs

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.

Associated Clinical Trials

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Citations

Apr 25, 2018·Future Oncology·Barbara MeloskyIra Jacobs
Sep 22, 2019·Drugs·Pier Luigi ZinzaniGiuseppe Curigliano
Mar 20, 2018·Dermatology and Therapy·Jose-Manuel CarrascosaRobert Strohal
Dec 19, 2020·Oncology and Therapy·Jerome Goldschmidt, Vladimir Hanes
Apr 9, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Louise C DruedahlAnna Birna Almarsdóttir
Jun 8, 2021·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Aqsa SafdarMuhammad Zaman

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