Authors of a study examined changes in pricing, market share, and utilization of the tumor necrosis factor (TNF)–α inhibitors infliximab, etanercept, and adalimumab as the first and second biosimilars for each molecule were introduced in Europe.
Authors of a study on price data in European countries found that market entry of the first infliximab, adalimumab, and etanercept biosimilars resulted in increased use of these biologics and “heterogeneous” price reductions. They also found a first-mover advantage, where the average market share captured by the first biosimilars of each molecule was much larger than that of the second biosimilars.
The study examined changes in pricing, market share, and utilization of the tumor necrosis factor (TNF)–α inhibitors infliximab, etanercept, and adalimumab as the first and second biosimilars for each molecule were introduced in Europe. The authors said that biologics accounted for 34% of medical expenditures in Europe in 2021, but have had “tremendous positive impact” on patients with cancers and autoimmune diseases. Development of biosimilars aims to expand patient access by reducing these costs.
The researchers analyzed IQVIA sales and volume data for biosimilar and originator infliximab, etanercept, and adalimumab products from 2008 to 2020 in 24 EU member states plus Norway, Switzerland, the United Kingdom, Serbia, and Bosnia and Herzegovina.
Prices Dropped Upon Biosimilar Entry, but Price Reductions Varied Between Molecules and Countries
For the first biosimilar entry, the average reduction in the volume-weighted average price (VWAP) per defined daily dose (DDD) was 14% for infliximab, 9% for etanercept, and 1% for adalimumab. For the second biosimilar entry, prices decreased by 26%, 9%, and 27%.
The changes in price varied widely between countries, for example, the change in the VWAP per DDD of infliximab after the first biosimilar entry ranged from a 3% increase in Finland to a 34% decrease in Lithuania.
The First Biosimilar for Each Molecule Gained a Market Share Advantage
The average market share captured by the first biosimilars entering the market was at least double that of the second biosimilars for all 3 molecules. In 2020, the market shares of the first and second biosimilars were 45% and 20% for infliximab, 36% and 15% for etanercept, and 23% and 6% for adalimumab. Again, the data varied widely between countries with a few reporting the second biosimilar captured a larger market share than the first for 1 or more molecules.
Competition and Originator Pricing Strategies
Overall prices of adalimumab, for which there was an average of 4.5 biosimilar entrants across countries within 2 years of the first biosimilar launch, decreased by 39%. Etanercept had an average of 1.6 biosimilar entrants and a 13% decrease in price. Infliximab had 2.3 entrants and a 25% decrease in price.
The authors say this finding suggests that a greater number of competitors led to larger price reductions, “underpinning that the market entry of more biosimilars is essential to promote price competition, and hence cost-savings.”They suggested the “marginal” price reductions for etanercept could be due the small number of available etanercept biosimilars.
The authors also looked at the response of the reference product manufacturer to the introduction of biosimilars, a determinant of biosimilar uptake “that could potentially jeopardize access to biosimilars.” Their results suggested a “pattern of aggressive price cuts” on the adalimumab reference product Humira led to low uptake of adalimumab biosimilars. They found this tactic concerning because it “may negatively impact biosimilar entry eventually leading to biosimilar manufacturers opting out of the market.”
Utilization and Patient Access
Utilization of all 3 anti-TNF biologics increased following the market entry of biosimilars, on average by 89%, 15%, and 22% for infliximab, etanercept, and adalimumab. Changes in utilization also varied, with some countries reporting decreases in utilization following biosimilar entry. The authors said some of these decreases could be attributed to switches from 1 anti-TNF molecule to another.
Also, although utilization of biologics increased after the introduction of biosimilar competition in Central and Eastern European countries, because of limited access to biologics overall, patient access to anti-TNF therapies remained lower in these countries than in Western Europe even after biosimilars were introduced.
To the authors’ knowledge, their study is the first that has investigated the advantage of the first biosimilar entrant across multiple European markets. A limitation of the study they cited is that the data they used in their analyses do not represent net prices, and therefore do not consider confidential discounts in the retail and hospital sectors.
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. doi:10.3389/fphar.2023.1151764