Abstract:Cancer represents a significant, and growing, burden on healthcare systems. This is driven, at least in part, by escalating cancer drug budgets. Loss of patent protection on biopharmaceuticals enables the development and production of similar biological medicines, or biosimilars. Biosimilars are currently available for use in oncology in the supportive care setting; the focus of biosimilar development is likely to switch to agents such as monoclonal antibodies. Available evidence indicates that biosimilars approved by regulatory authorities offer a safe and effective alternative to originator biological therapies. They also offer potentially significant cost savings to healthcare payers. The greater affordability of biosimilars may also result in clinical benefits, through earlier and wider appropriate therapy use and release of funding to be used elsewhere in clinical care. Greater adoption of biosimilars represents a key approach to reducing healthcare expenditure and improving patient access to important treatments.Submitted:?2 April 2013;?Revised:?24 May 2013;?Accepted:?28 May 2013;?Published online first:?10 June 2013The healthcare burden of cancerCancer places a significant, and growing, burden on healthcare systems around the world. Improved therapies and changing demographics are conspiring to increase the already considerable drain on resources. On the one hand, population growth and ageing will increase the number of new cancer cases in the coming years [1]; on the other, advances in diagnosis and management will extend the length of treatment required for each patient [2]. Many novel treatments or supportive therapies for patients with cancer are biological agents. In fact, cancer is the major indication for six of the ten best-selling biological therapies [3]. The cost of new cancer drugs is rising every year [4], due in part to the higher research and development costs associated with biological rather than chemical medicines. In the US, the cost of cancer drugs rose four-fold between 1998 and 2008 [5], with more than 90% of the oncology therapies approved by the Food and Drug Administration (FDA) between 2005 and 2009 costing in excess of US$20,000 for three months of treatment [6]. This growing cost burden is also being felt across Europe. The French budget for cancer therapies, for example, more than doubled from Euros 474 million to Euros 975 million between 2004 and 2008 [7]. These different factors form a complex situation that requires rapid action [8, 9].Patent expiration on biopharmaceutical products provides pharmaceutical companies with an opportunity to develop and produce similar biological medicinal products, or biosimilars [10]. These agents may offer one way of controlling cancer drug expenditure while simultaneously expanding patient access to important treatments [11]. This paper will review current and future use of biosimilars in oncology, regulatory aspects of biosimilar approval, and current and future impact of these agents on cancer drug expenditure.Biosimilars in oncology: regulatory considerationsBiological therapies are large, highly complex molecules derived from living cells or organisms. Traditional chemical medicines, by contrast, are usually simple molecules of low molecular weight, synthesised by chemical means. These differing complexities and methods of manufacture create an important difference between biosimilars and conventional generic drugs: while chemical generics can be fully characterised as identical to the originator product, biosimilars cannot. Biological therapies are inherently variable, creating unavoidable differences between even subsequent batches of the same product [12]. An expiring patent does not necessarily provide access to the precise manufacturing conditions used in producing the originator therapy, including, for example, the relevant cell line clone and growth medium. It therefore cannot be guaranteed that biosimilar products are identical to t
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