Clinical considerations for the development of biosimilars in oncology

Mark A. Socinski, Giuseppe Curigliano, Ira Jacobs, Barry Gumbiner, Judith MacDonald, Dolca Thomas

Research output: Contribution to journalArticlepeer-review


Despite availability of biologic therapies, limited patient access to many of the most-effective cancer treatments affects overall health outcomes. To address this issue, many governments have enacted legislation for the approval of biosimilars. The term "biosimilar" refers to a biologic product that is developed to be highly similar, as opposed to identical, to a licensed biologic product (the reference or innovator product), such that, per US Food and Drug administration draft guidelines, "no clinically meaningful differences [exist] between the biological product and the reference product in terms of safety, purity, and potency." This article presents some considerations about the development of biosimilars in cancer treatment through an overview of biosimilars from a clinical perspective. Topics covered include the development requirements and unique regulatory requirements for biosimilars, labeling considerations, potential limitations to the uptake of biosimilars, and review of some biosimilars in development for oncology indications.

Original languageEnglish
Pages (from-to)286-293
Number of pages8
Issue number2
Publication statusPublished - Mar 13 2015


  • Biologic therapy
  • Biosimilar
  • Clinical
  • Monoclonal antibody
  • Regulatory

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology


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