OBJECTIVES: Since approval of the first biosimilar in the European Union (EU) in 2006, many European countries have introduced regulations to incentivize biosimilar uptake to lower spending, but the degree of implementation varies. The aim of this research was to analyze the availability and uptake of biosimilars in the 5 largest European markets (France, Germany, Italy, Spain and the United Kingdom [UK]).

METHODS: Availability of biosimilars approved by the European Medicines Agency (EMA) between 2006 and April 2023 was determined by country using national drug databases. Biosimilar uptake was assessed via a targeted literature review along with a grey literature search conducted in April 2023.

RESULTS: 18 biosimilar molecules and 75 brands have been approved by the EMA since 2006 and almost all are available in the EU4 and UK ranging from 15 in Spain to 18 in Germany. Despite having the highest availability Germany had the lowest uptake in 2021 at around 15%, whereas Italy had an uptake of 43%. Total data is not available for the UK but in 2019 uptake in England ranged from 74% for adalimumab to 94% for trastuzumab. Uptake varies by molecule and is increasing with time, 2 years after authorization uptake of adalimumab and trastuzumab in Germany was 70% and 60%, respectively.

Uptake rates of biosimilars vs. originators varies between countries, regions and molecules but is increasing. Low penetration may be explained by a lack of confidence in biosimilars among physicians and patients and pricing mechanisms not favoring biosimilar use.

CONCLUSIONS: The EU is a pioneer in biosimilar authorization; however, the degree of uptake at a national and regional level varies significantly in individual European markets. Biosimilar manufacturers need to thoroughly assess measures in place that may facilitate or impede a successful market entry to maximize the potential for biosimilars in the individual European markets.