OBJECTIVES: Determine if EU pricing and reimbursement (P&R) bodies have revised their P&R approval processes for biosimilar medicines to enable faster access and optimize the potential healthcare savings. This study analyzed the biosimilar P&R procedures across Europe to determine how these differed to the standard and generic P&R approval processes. METHODS: OECD pharmaceutical spend data across Europe was utilized to identify the European countries that account for 90% of EU pharmaceutical spend. The official P&R websites for these 12 countries (France, Germany, Italy, Spain, UK, Austria, Poland, Belgium, Netherlands, Sweden, Greece, and Switzerland) were identified and analyzed to determine if biosimilar P&R process followed the standard, generic or a specific biosimilar P&R approval process. If no biosimilar P&R documents were identified, the inference was that they follow the standard P&R approval process. RESULTS: Of the 12 countries reviewed, 8 require biosimilars to undergo the full standard P&R process, often requiring submission of comparative clinical data and development of health economic and/or budget impact models. In addition, Switzerland and Spain mandated an additional biosimilar price discount be applied. 3 markets applied the generic approval process to biosimilars, enabling faster access to market. Italy was the only country having a specific, abridged biosimilar P&R pathway, where faster access to market is achieved if a pre-specified biosimilar price discount, dependent on the sales of the reference product, is applied. CONCLUSIONS: In the majority of European countries biosimilars, unlike generics, are still required to undergo a comprehensive standard P&R process. Such processes are time consuming, resource intensive and costly for both the manufacturers and P&R bodies. The implication is that European payers have yet to consider biosimilars to be clinically comparable to their reference products or to fully recognise the potential healthcare savings from having an expedited biosimilar P&R approval process.