Currently authorised, top selling monoclonal antibodies are sold at prices ranging from €1000-€100.000 per year, whereas the estimated costs of goods for producing monoclonal antibodies are estimated at around 2.3% of the sales price.1 Clearly, there is great opportunity to reduce the price of these products once their patents expire, thereby improving access to medicines.
However, developing biosimilars requires considerable technological expertise. Compared to small molecule generics, the development process is long (5-10 years) and costly, with estimated investment costs ranging from US$ 40-200 Million for a biosimilar. Biosimilar products authorised in Europe are being sold at prices that are only 30%-40% lower than the innovator.2 While this may lead to considerable cost savings, such high costs still put these products out of reach for most patients in LMICs. In order to improve access to biotherapeutics in LMICs, the costs of these treatments require substantial reductions.
1. Kelley, B. Industrialization of mAb production technology: the bioprocessing industry at a crossroads. MAbs 1, 443-452 (2009).
2. IMS health. Shaping the biosimilars opportunity: A global perspective on the evolving biosimilars landscape. Available from: http://www.imshealth.com/ims/Global/Content/Home%20Page%20Content/IMS%20News/Biosimilars_Whitepaper.pdf [Accessed 17 July 2012]. (2011).