OBJECTIVES: The financial impact of Loss of Exclusivity (LoE) on pharmaceutical companies can be significant and can vary depending on specific drug and market conditions. The aim of this research was to characterize the impact of LoE and company mitigation strategies on list prices in 8 European Countries; mainly Europe-5 and Denmark, Sweden, and Norway.

METHODS: Price erosion trends both pre- and post-LOE from a small sample of 8 originator drugs across Immunology, Neurology, and Oncology that have lost exclusivity in Europe between 2015 and 2021 were analysed, along with the prices of their respective generics/biosimilars. All pricing data was extracted from the GPI pulse database in May 2023.

RESULTS: Notable variations were observed in the price trends post-LoE across European countries. The highest price reductions on average were observed in Spain, Sweden, and Germany, but it was never the same drug representing the maximum erosion trend in each of these countries. In Sweden, Germany, the UK, and Denmark biosimilars and generics could be priced at more than a 90% discount relative to the originator. While 88% of brands in our sample experienced a list price drop in France followed by 75% in Denmark, no brands had a decrease in list prices in the UK. Interestingly, we noted that Denmark and France, saw the largest proportion of originators with documented price drops prior to LoE.

CONCLUSIONS: Price erosion often documented following LoE in European countries can be both a function of public policy as well as part of a mitigation strategy by pharmaceutical companies. It is critical to segment markets based on pricing regulations and substitution laws and identify the strategies that would have the most favourable outcome while minimising the impact price reductions could have on global revenues due to International Reference Pricing (IRP).