Clinical considerations for the development of biosimilars in oncology

作者：Socinski Mark A; Curigliano Giuseppe; Jacobs Ira^*; Gumbiner Barry; MacDonald Judith; Thomas Dolca

来源：mAbs, 2015, 7(2): 286-293.

DOI：10.1080/19420862.2015.1008346

• biosimilar
• biologic therapy
• clinical
• monoclonal antibody
• regulatory

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.

• 出版日期2015-4