Broer Linda N, Knapen Daan G, de Groot Derk-Jan A, Mol Peter G M, Kosterink Jos G W, de Vries Elisabeth G E, Lub-de Hooge Marjolijn N
Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
iScience. 2024 May 24;27(6):110115. doi: 10.1016/j.isci.2024.110115. eCollection 2024 Jun 21.
Monoclonal antibodies are important cancer medicines. The European Medicines Agency (EMA) approved 48 and the Food and Drug Administration (FDA) 56 anticancer monoclonal antibody-based therapies. Their high prices burden healthcare systems and hamper global drug access. Biosimilars could retain costs and expand the availability of monoclonal antibodies. In Europe, five rituximab biosimilars, six trastuzumab biosimilars, and eight bevacizumab biosimilars are available as anti-cancer drugs. To gain insight into the biosimilar landscape for cancer treatment, we performed a literature search and analysis. In this review, we summarize cancer monoclonal antibodies' properties crucial for the desired pharmacology and point out sources of variability. The analytical assessment of all EMA-approved bevacizumab biosimilars is highlighted to illustrate this variability. The global landscape of investigational and approved biosimilars is mapped, and the challenges for access to cancer biosimilars are identified.
单克隆抗体是重要的抗癌药物。欧洲药品管理局（EMA）批准了48种，美国食品药品监督管理局（FDA）批准了56种基于单克隆抗体的抗癌疗法。它们的高价格给医疗保健系统带来负担，并阻碍全球药物可及性。生物类似药可以控制成本并扩大单克隆抗体的可及范围。在欧洲，有五种利妥昔单抗生物类似药、六种曲妥珠单抗生物类似药和八种贝伐单抗生物类似药可作为抗癌药物使用。为深入了解癌症治疗生物类似药的情况，我们进行了文献检索和分析。在本综述中，我们总结了癌症单克隆抗体对于理想药理学至关重要的特性，并指出了变异性的来源。重点介绍了对所有EMA批准的贝伐单抗生物类似药的分析评估，以说明这种变异性。绘制了研究性和已批准生物类似药的全球情况，并确定了获取癌症生物类似药面临的挑战。
