» Articles » PMID: 38974466

Monoclonal Antibody Biosimilars for Cancer Treatment

Overview
Journal iScience
Publisher Cell Press
Date 2024 Jul 8
PMID 38974466
Authors
Affiliations
Soon will be listed here.
Abstract

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.

References
1.
Cohen M, Chen H, Shord S, Fuchs C, He K, Zhao H . Approval summary: Cetuximab in combination with cisplatin or carboplatin and 5-fluorouracil for the first-line treatment of patients with recurrent locoregional or metastatic squamous cell head and neck cancer. Oncologist. 2013; 18(4):460-6. PMC: 3639534. DOI: 10.1634/theoncologist.2012-0458. View

2.
Reusch D, Tejada M . Fc glycans of therapeutic antibodies as critical quality attributes. Glycobiology. 2015; 25(12):1325-34. PMC: 4634315. DOI: 10.1093/glycob/cwv065. View

3.
Kim E, Balser S, Rohr K, Lohmann R, Liedert B, Schliephake D . Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC. JTO Clin Res Rep. 2022; 3(1):100248. PMC: 8713120. DOI: 10.1016/j.jtocrr.2021.100248. View

4.
Kvien T, Patel K, Strand V . The cost savings of biosimilars can help increase patient access and lift the financial burden of health care systems. Semin Arthritis Rheum. 2022; 52:151939. DOI: 10.1016/j.semarthrit.2021.11.009. View

5.
Gonsalves G, Yamey G . The covid-19 vaccine patent waiver: a crucial step towards a "people's vaccine". BMJ. 2021; 373:n1249. DOI: 10.1136/bmj.n1249. View