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Biosimilars Biosimilars in Oncology Andrew D Zelenetz Memorial Sloan-Kettering, Cancer Center, New York, New York, US Abstract The escalating cost of cancer care is placing an increasing burden on healthcare systems worldwide, largely a result of expensive biologic therapies. With the patents on many biologics expiring, interest in biosimilars is rising. Biosimilars of biologic agents used for cancer treatment and supportive care are making their appearance in the US; this article therefore aims to increase understanding of the biosimilars concept. Biosimilars are very comparable to their reference products, but because of their size and complexity, are not identical. However, the inherent structural differences between biologics and their reference products may not translate to clinically meaningful differences in efficacy and safety. Biosimilars offer potential cost savings but present a challenge in terms of establishing a regulatory pathway. Regulatory approval requires comparative analytical and clinical studies in order to characterize and demonstrate the absence of clinically meaningful differences between biosimilars and their reference products. Initial approval may not include interchangeability, as additional evidence may be required before a biosimilar can be designated interchangeable with its reference product. A framework for the approval of biosimilars was established by the European Medicines Agency (EMA) in 2006 with the first biosimilar approved in April, 2006. Thus, the experience in Europe provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving patient access without compromising patient outcomes, but clinician education and acceptance is crucial. Keywords Biosimilar, biologic therapies, oncology, reference product Disclosure: Andrew D Zelenetz has received research support from Genentech/Roche, MEI Pharmaceuticals, BeiGene, BMS, Gilead, and Mirati Pharmaceuticals, and participated in advisory boards/consultancy for Genentech/Roche, Gilead, Celgene, Adaptive Biotechnology, Hospira, and Novartis. Acknowledgements: Medical writing assistance was provided by Katrina Mountfort at Touch Medical Media, funded by Sandoz. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: March 3, 2016 Accepted: April 1, 2016 Citation: Oncology & Hematology Review, 2016;12(1):22–8 Correspondence: Andrew D Zelenetz, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10065, US. E: a-zelenetz@ski.mskcc.org Support: The publication of this article was supported by Sandoz. The views and opinions expressed are those of the author and do not necessarily reflect those of Sandoz. Cancer places a significant and growing burden on healthcare systems around the world; it is the second most common cause of death in the US and accounts for nearly one in four deaths. 1 About 1,665,540 new cancer cases are expected in the US in 2014. While population growth and aging will increase the number of new cancer cases in the coming years, 2 advances in diagnosis will extend the treatment duration required for each patient; the average median duration of treatment with a new drug has risen from 181 days in 1995–1999 to 263 days in 2010–2014. 3 Healthcare spending is projected to grow at an average rate of 5.7% during the period 2013–2023, 1.1 percentage points faster than the expected average annual growth in the gross domestic product (GDP). 4 Cancer care costs are rising faster than overall healthcare costs with cancer drug innovation estimated to reach nearly $100 billion in 2018. 5 As a result, the spiraling cost of cancer care, in particular the cost of cancer therapeutics that achieve only marginal benefits, is under increasing scrutiny. 6–9 In the past 20 years, recombinant biologics that target specific receptors have made a substantial impact on cancer therapeutics and represent 22 approximately 50% of the pharmaceutical market in oncology. 10,11 However, these drugs are expensive and are partly responsible for escalating healthcare costs. Year-on-year biologic spending is growing at more than double the rate for small molecule drugs. 12 In 2010, worldwide sales of all biologics approached the $100 billion mark 13 and it has been estimated that these could account for more than half of new drug approvals within the next years. 14,15 However, the patents on biologic therapeutics are beginning to expire (see Figure 1), 16 allowing the development of biosimilars. 17,18 Biosimilars represent an opportunity to reduce healthcare spending while increasing access to these important treatments without compromising patient outcomes. Currently, the majority of biosimilar products available for use in oncology are in the supportive care setting; however, their use is increasing rapidly, with an expected shift in focus to agents that offer life-extending benefits, including monoclonal antibodies (mAbs). Biosimilar development programs for therapeutics including bevacizumab, cetuximab, rituximab, and trastuzumab; and supportive care products including epoetin alfa, filgrastim, and pegfilgrastim, are currently ongoing. TOUCH ME D ICA L ME D IA