OBJECTIVES: Compared to small molecule generics, biosimilars have different price drivers due to greater manufacturing complexity and stronger regulatory hurdles.  We looked to investigate historic trends in biosimilars pricing and assess what may change in the future.  In addition, we aimed to understand how the recent FDA guidelines will shape pricing of biosimilars in the US. METHODS: In order to understand the historic trends shaping biosimilars pricing, we conducted secondary research into the pricing of 14 biosimilars in EU5 markets.  Focusing on qualitative analysis, we assessed three potential factors that shape current pricing: 1) Launch date; 2) Number of biosimilars available; and 30 Therapy area. Primary research was conducted by surveying a selection of payers in order to understand the current price drivers and how these will potentially change in the future.  We also assessed their expectations on how FDA pathway regulations will affect pricing in the US. RESULTS: Historical analysis of biosimilar pricing indicated similar pricing across the sample, with average pricing at a 20-30% discount relative to the originator. These results indicated no significant correlation between the number of biosimilars available, launch date or therapy area, suggesting that common drivers such as development and manufacturing costs shape pricing across therapy areas. Payers noted that future manufacturing costs (particularly for monoclonal antibodies), regulatory hurdles, and phase IV trial requirements will maintain upward pressure on biosimilar prices, but increasing competition over time would likely bring down prices relative to originators. CONCLUSIONS: Historically, biosimilar pricing has been driven by the date of launch and therapy area, in addition to the high R&D costs of manufacturing.  Predictions for the future indicate that biosimilars pricing will maintain current levels due to competing pressures.  Payers in the US foresaw similar pricing trends, but did not expect as great a level of discounting seen in the EU.