OBJECTIVES: Biosimilars hold much promise for healthcare systems by improving patient access to efficacious and established treatments whilst mitigating costs. Despite biosimilar policies implemented across the EU, the effects of these measures remains unclear due to complex interplays between prescribing requirements, switching guidelines and tendering. This study aims to assess the impact of biosimilar policies on pricing dynamics in France, Germany, Italy, Spain and the United Kingdom.

METHODS: A targeted literature review was conducted to explore policies, prescribing guidelines and reimbursement requirements for biosimilars across Europe. Following this, launch dates and list prices of biosimilars approved by EU in last 5 years were extracted from NAVLIN database. Analysis was conducted to assess the correlation between biosimilar policies and prices.

RESULTS: Across majority of scope countries, HTAs are not required for biosimilars, and switching is at physicians' discretion. However, in Italy, HTAs are mandatory, and prescribers must adhere to guidelines. In-patient setting tendering is applied in all counties but only France, Italy and Spain have regulated pricing policies. Financial models including benefit sharing models and prescription quotas were mostly implemented in Germany, France and the UK. From Jan 2019 till May 2024, a total of 17 biosimilars are available in the EU. The average per pack launch price ranged between €581 to €1,128. Biosimilars in UK experienced the highest price erosion (~60% discount from launch price), followed by France and Germany with 20% and 10% discount, respectively.

CONCLUSIONS: Despite relaxed price-setting in the UK, biosimilars there experienced the most significant price erosion compared to other European markets, likely due to centralized negotiations and switching polices mandated by NHS directives. To fully understand the underlying impact of these policies, further research is needed to investigate policy implementation at the sub-national level, particularly interactions between institutions, physicians, and pharmacists.