Monoclonal antibody biosimilars for cancer treatment
Linda N. Broer,
Daan G. Knapen,
Derk-Jan A. de Groot,
Peter G.M. Mol,
Jos G.W. Kosterink,
Elisabeth G.E. de Vries,
Marjolijn N. Lub-de Hooge
Affiliations
Linda N. Broer
Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Daan G. Knapen
Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Derk-Jan A. de Groot
Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Peter G.M. Mol
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Jos G.W. Kosterink
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; Department of Pharmaco-, Therapy-, Epidemiology- and Economy, Groningen Research Institute for Pharmacy, University of Groningen, Groningen, the Netherlands
Elisabeth G.E. de Vries
Department of Medical Oncology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands
Marjolijn N. Lub-de Hooge
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands; Corresponding author
Summary: 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.
