Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis

Abstract

Background: The level of competition achieved following biosimilars market availability varies by country, care setting and molecule. Hence, biosimilars contribution to attaining price reductions and extended access to treatments can also vary.Objective: The aim of this study is to capture market dynamics for tumor necrosis factor (TNF)-alpha inhibitors and competing molecules in Southern European markets (2011–2020), and to evaluate the benefits of the competition generated by the availability of biosimilars.Methods: This study is based on a literature review examining market characteristics for TNF-alfa inhibitors and competing immunomodulator molecules, and on the quantitative analysis of market data for these molecules in Italy, Portugal and Spain.Results: Following biosimilars availability in Italian, Portuguese and Spanish markets, there has been an expansion in the overall access to TNF-alfa inhibitor pharmaceuticals. Further, savings have been generated within the TNF-alfa inhibitors class even after the increased use of these molecules. However, the potential of infliximab, etanercept and adalimumab biosimilars to generate price competition outside of their own drug class appeared limited in the studied markets. Considering this limitation and that shifts towards on-patent and higher-cost therapies have occurred after TNF-alfa inhibitor biosimilars availability, the importance of investing in biosimilars development for still on-patent immunology biologics is emphasized.Conclusion: This study highlights the need for policies that do not only seek higher utilization of biosimilars, but that also support a sustainable market for these products. This is expected to foster the future development of biosimilar medicines.

Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries

“…Additionally, the price of the originator significantly decreased, by 89% in the Netherlands and by 80% in the EU tender market, to stave off the use of biosimilars [ 34 , 35 ]. Biosimilar competition has also led to considerable price reductions in Denmark, England, and southern European countries, such as in Italy, Portugal, and Spain [ 31 – 33 ]. The more price reductions, the greater the potential cost savings.…”

“…Barcina Lacosta et al, identified that the introduction of TNF-α inhibitor biosimilars (those for infliximab, etanercept, and adalimumab) resulted in cost savings despite similar or increased consumption in Southern European countries like Italy, Portugal, and Spain. They also observed heterogeneous utilization of biosimilars in Italy and Spain, which could be associated with the decentralized healthcare systems [ 31 ]. Vogler and colleagues highlighted that the policies to encourage the use of biosimilars in European countries have clearly demonstrated potential savings [ 39 ].…”

Charting the Etanercept Journey: Tracing Cost Dynamics in Poland’s Off-Patent Market from Reference Drug Rivalry to Biosimilar Monopoly

“…In countries where biosimilar or reference drug use is obligatory and fixed in a tender, various approaches for introducing a new agent exist [ 19 , 21 , 29 , 30 ]. Regional- and nation-wide strategies include a mandate of the selected agent for all or only for new patients.…”

“…In order to encourage wider uptake of biosimilars, various countries are implementing different incentive systems [ 19 , 33 – 36 ]. Studies from various European countries, including Poland, show that the share of off-patent drugs is steadily decreasing, at the expense of more modern on-patent therapies [ 10 , 21 , 22 , 30 ]. While selecting the cheapest drug from the off-patent group guarantees its market share, there is no priority over other on-patent drugs, often with different modes of action.…”