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.

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.

Figure 1.

Demonstrating biosimilarity is built first on a foundation of an analytical comparison of structural and functional similarity to the reference product, supported by non-clinical testing, and clinical evaluation in the intended treatment population. Biosimilarity is considered demonstrated based on the totality of the evidence from all evaluations, with each step supported by the preceding one.