title: What do oncologists need to know about biosimilar products?
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.
authors.affiliation: 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, Shatin, Hong Kong, China.
authors.forename: Linda K S
authors.initials: LK
authors.lastname: Leung
authors.affiliation: Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Kevin
authors.initials: K
authors.lastname: Mok
authors.affiliation: Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.
authors.forename: Calvin
authors.initials: C
authors.lastname: Liu
authors.affiliation: 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, Shatin, Hong Kong, China. chanlam_stephen@cuhk.edu.hk.
authors.forename: Stephen L
authors.initials: SL
authors.lastname: Chan
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D017410:Practice Guidelines as Topic
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals
keywords: Biologic products; Biosimilar products; Oncology; Regulation