• Charles L Bennett, Brian Chen, Terhi Hermanson, Michael D Wyatt, Richard M Schulz, Peter Georgantopoulos, Samuel Kessler, Dennis W Raisch, Zaina P Qureshi, Z Kevin Lu, Bryan L Love, Virginia Noxon, Laura Bobolts, Melissa Armitage, John Bian, Paul Ray, Richard J Ablin, William J Hrushesky, Iain C Macdougall, Oliver Sartor, and James O Armitage.
• The Southern Network on Adverse Reaction (SONAR) project, South Carolina Center of Economic Excellence for Medication Safety, South Carolina College of Pharmacy, University of South Carolina, Columbia, SC, USA; University of South Carolina, Arnold School of Public Health, Columbia, SC, USA; WJB Dorn VA Medical Center, Columbia, SC, USA; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bennettc@sccp.sc.edu.
• Lancet Oncol. 2014 Dec 1; 15 (13): e594-e605.

AbstractBiological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.Copyright © 2014 Elsevier Ltd. All rights reserved.

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