Biosimilars: Extrapolation for oncology

Giuseppe Curigliano, Darran P. O'Connor, Julie A. Rosenberg, Ira Jacobs

Research output: Contribution to journalArticlepeer-review

Abstract

A biosimilar is a biologic that is highly similar to a licensed biologic (the reference product) in terms of purity, safety and efficacy. If the reference product is licensed to treat multiple therapeutic indications, extrapolation of indications, i.e., approval of a biosimilar for use in an indication held by the reference product but not directly studied in a comparative clinical trial with the biosimilar, may be possible but has to be scientifically justified. Here, we describe the data required to establish biosimilarity and emphasize that indication extrapolation is based on scientific principles and known mechanism of action.

Original languageEnglish
JournalCritical Reviews in Oncology/Hematology
DOIs
Publication statusAccepted/In press - Jan 22 2016

Keywords

  • Biosimilar
  • Cancer
  • Extrapolation
  • Monoclonal antibody

ASJC Scopus subject areas

  • Oncology
  • Hematology
  • Geriatrics and Gerontology

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