doi: 10.1186/s40880-016-0151-x

What do oncologists need to know about biosimilar products?

Linda K. S. Leung, Kevin Mok, Calvin Liu and Stephen L. Chan

State Key Laboratory in Oncology in South China, Department of Clinical Oncology, Sir YK Pao Center for Cancer, Hong Kong Cancer Institute and Prince of Wales Hospital, The Chinese University of Hong Kong

[Abstract] Many biologic products have improved the outcomes of cancer patients, but the costs can substantially burden healthcare systems. Biosimilar products can potentially reduce drug costs and increase patient access to beneficial treatments. Approval of a biosimilar product relies on the demonstration of “comparability” or “no clinically meaningful differences” as compared to its reference biologic product. Biosimilar products for erythropoietin, granulocyte colony-stimulating factor, trastuzumab, and rituximab are already available, and the regulatory processes in various countries are constantly evolving. It is important that oncologists be familiar with the potential issues surrounding the clinical use of biosimilar products. In this review article, we provide background information about biosimilar products and their regulatory approval processes, followed by a discussion of individual biosimilar drugs.

Chinese Journal of Cancer 2016, Volume: 35, Issue 11

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Linda K. S. Leung, Kevin Mok, Calvin Liu and Stephen L. Chan. What do oncologists need to know about biosimilar products?. Chin J Cancer. 2016, 35:91. doi:10.1186/s40880-016-0151-x


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