title: Clinical considerations for the development of biosimilars in oncology.
abstract: 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.
authors.affiliation: a University of Pittsburgh ; Pittsburgh , PA USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Curigliano
authors.forename: Ira
authors.initials: I
authors.lastname: Jacobs
authors.forename: Barry
authors.initials: B
authors.lastname: Gumbiner
authors.forename: Judith
authors.initials: J
authors.lastname: MacDonald
authors.forename: Dolca
authors.initials: D
authors.lastname: Thomas
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D017277:Drug Approval; D017408:Guidelines as Topic; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: CI, confidence interval; EBE, European Biopharmaceutical Enterprises; EMA, European Medicines Agency; EPAR, European Public Assessment Report; FDA, US Food and Drug Administration; HER2, human epidermal growth factor receptor 2; MBC, metastatic breast can; biologic therapy; biosimilar; clinical; monoclonal antibody; regulatory