OBJECTIVES: This study aims to analyze multiple facets of biosimilar competition of TNF-alpha inhibitors in Europe by exploring the existence of a biosimilar first-mover advantage, pricing strategies of originator companies, and the evolution in treatment access.

METHODS: Annual sales and volume data on biosimilar and originator infliximab, etanercept, and adalimumab in European countries between 2008 and 2020 were provided by IQVIA. Descriptive analyses were conducted based on the evolution in ex-manufacturer price per defined daily dose, biosimilar and originator market shares, and utilization which was measured by the number of defined daily doses per 1000 inhabitants per day.

RESULTS: Market entry of the first biosimilars of infliximab and adalimumab resulted in a decrease of the volume weighted average price per defined daily dose by -13.6% and -0.9% on average, whilst the second biosimilars resulted in a decrease by -26.4% and -27.3%, respectively. The first and second etanercept biosimilars generated a similar decrease in the volume weighted average price per defined daily dose by -9.3% and -9.1% on average, respectively. The first biosimilars captured on average at least twice as large market share as the second biosimilars for all substances. Sharp reductions in the price per defined daily dose of originator adalimumab (Humira®) in most countries indicated a pricing strategy coupled with low uptake of adalimumab biosimilars. Utilization of infliximab, etanercept, and adalimumab following biosimilar entry increased by an average of 89%, 15%, and 22%, respectively.

CONCLUSIONS: Overall, this study revealed that biosimilar entry results in increased utilization and reduction in list prices, although at a heterogenous rate among TNF-alpha inhibitors and European markets. Observed trends in market shares indicate a biosimilar first-mover advantage whereas anti-competitive practices limit market uptake. Policy measures need to be taken to ensure a competitive but sustainable market over the long-term.