title: Biosimilars: Extrapolation for oncology.
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.
authors.affiliation: European Institute of Oncology, Division of Experimental Therapeutics, Milano, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Curigliano
authors.affiliation: Dept. of Molecular & Cellular Therapeutics, Royal College of Surgeons in Ireland, 123 Street Stephens Green, Dublin 2, Ireland.
authors.forename: Darran P
authors.initials: DP
authors.lastname: O'Connor
authors.affiliation: Pfizer Inc., Groton, CT, USA.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Rosenberg
authors.affiliation: Pfizer Inc., 235 East 42nd Street, New York, NY 10017-5755, USA. Electronic address: ira.jacobs@pfizer.com.
authors.forename: Ira
authors.initials: I
authors.lastname: Jacobs
mesh_terms: D000818:Animals; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: Biosimilar; Cancer; Extrapolation; Monoclonal antibody