Biosimilars: Extrapolation for oncology

https://doi.org/10.1016/j.critrevonc.2016.06.002Get rights and content
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Highlights

  • A biosimilar is a biologic that is highly similar to a licensed biologic.

  • Biosimilarity is established based on analytical, non-clinical and clinical studies.

  • Extrapolation is essential to the biosimilar concept and is based on scientific principles.

  • The main rationale for data extrapolation is to avoid unnecessary studies.

  • Biosimilars function similar to the originators including in indications that were licensed based on extrapolation.

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.

Keywords

Cancer
Extrapolation
Biosimilar
Monoclonal antibody

Cited by (0)

Giuseppe Curigliano, MD, PhD, is Director at the IEO, Division of Experimental Therapeutics. He is a clinician and researcher specializing in breast cancer and new drug development. Dr Curigliano is associate editor for The Breast, and a member of the editorial board of Journal of Clinical Oncology, Annals of Oncology and Cancer Treatment Reviews. Dr Curigliano has published many papers and reviews for a number of prestigious oncology journals.

Darran P. O’Connor, PhD, is Senior Lecturer in Clinical Pharmacology in the Department of Molecular & Cellular Therapeutics at the Royal College of Surgeons in Ireland. He is a cancer biologist focused on the discovery, validation and clinical translation of novel cancer biomarkers.

Julie Ann Rosenberg, MD, is a Senior Director Asset Lead, Biosimilars, Pfizer Worldwide Research and Development, United States.

Ira A. Jacobs, MD, MBA, FACS, is a fellowship trained surgical oncologist who is the oncology biosimilars global medical lead at Pfizer, Inc.