Biosimilars Increased Utilization, Reduced Price in European Markets

The continued biosimilar competition resulted in increased utilization and decreased price, according to a study published in Frontiers in Pharmacology.¹ Investigators noted trends in market shares may be indicative of a biosimilar first-mover advantage, while pricing strategies designed to be anti-competitive could limit market uptake. Additionally, a heterogenous rate among tumor necrosis factor (TNF)-alpha inhibitors was observed.

Elif Car, PhD

Credit: LinkedIn.com

“With numerous biologics and blockbuster brands facing patent expiry, a window of opportunity opens up for biosimilar manufacturers, with time to market being a key driver of biosimilar uptake,” wrote Elif Car, PhD, Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium, and colleagues. “The existence of a first-mover advantage of biosimilars and its impact on market share has not been extensively explored yet in Europe.”

Benefits of biosimilar competition include cost-savings, resulting in a price competition which may lead to price reductions in both originator biologic as well as the whole product line. Biosimilar prices are generally 10-35% lower than biologics, which may improve patient access to treatment. However, restrictions are still reported in the European market, which may indicate an inconsistent biosimilar uptake.²

To evaluate the factors of biosimilar competition of TNF-alpha inhibitors in European markets, investigators analyzed the biosimilar first-mover advantage, the evolution in patient access, and the pricing strategies of originator companies. To achieve this, they used sales and volume data on biosimilars and originators for infliximab, adalimumab, and etanercept between 2008 and 2020, provided by IQVIA. The European countries included in the assessment were 24 European Union Member States, the United Kingdom, Norway, Switzerland, Serbia, Bosnia, and Herzegovina.

The ex-manufacturer price per defined daily dose (DDD) was used to determine the sales value and the volume data were translated into the number of DDDs per 1000 inhabitants per day. The evolution in price per DDD, and trends in market shares and utilizations for both the biosimilar and originator were used for descriptive analyses.

The market entry of the first biosimilars of adalimumab and infliximab resulted in a decrease of the volume-weighted average price (VWAP) per DDD by .9% and 13.6%, respectively. The second biosimilars resulted in a decrease of 27.3% and 26.4%, respectively. Regarding the first and second etanercept biosimilars, a similar decrease in the VWAP per DDD was observed by 9.3% and 9.1%, respectively.

The average market share captured by the first biosimilars was at least 2 times as large as the second biosimilars for all molecules evaluated. The sharp reductions in price per DDD of adalimumab in most countries assessed demonstrated a pricing strategy resulting in low uptake of adalimumab biosimilars.

The use of infliximab, adalimumab, and etanercept following biosimilar entry increased by 88.9%, 22.4%, and 14.6%, respectively. However, the introduction of biosimilar competitors was not correlated to an increase in treatment access for these molecules across all European countries. This indicated a shift in biosimilars use from 1 molecule to another.

Investigators noted that the data used do not represent net prices and, therefore, do not consider certain retail and hospital discounts. Further, parallel exporting could not be adjusted or identified for because volume data were described as the number of units sold in each country.

“Authorities should take this information into account to develop policy measures targeting different market dynamics to ensure cost-savings from biosimilar competition in long-term,” investigators concluded. “Therefore, healthcare payers should aim to achieve a level-playing field that supports the market participation of multiple (originator and/or biosimilar) manufacturers to ensure a sound bargaining power—beyond price alone—in the presence of various alternative sources of biologic medicines.”

References

1. ^{Car E, Vulto AG, Houdenhoven MV, Huys I, Simoens S. Biosimilar competition in European markets of TNF-alpha inhibitors: a comparative analysis of pricing, market share and utilization trends. Front Pharmacol. 2023;14:1151764. Published 2023 Apr 21. doi:10.3389/fphar.2023.1151764}
2. ^{Jang, D. I., Lee, A. H., Shin, H. Y., Song, H. R., Park, J. H., Kang, T. B., et al. (2021). The role of tumor necrosis factor alpha (TNF-α) in autoimmune disease and current TNF-α inhibitors in therapeutics. Int. J. Mol. Sci. 22 (5), 2719. doi:10.3390/ijms22052719}