Review Highlights Most Popular European Policies to Boost Biosimilar Uptake

A systematic review, published in Frontiers in Public Health, examined the policy landscape associated with increased biosimilar uptake in Europe, finding tender systems were very common among member states and automatic substitution was rarely utilized.

Longer lifespans and low birth rates in Europe have resulted in a large aging population, which poses significant economic and social challenges for the region. This demographic shift leads to more years lived with chronic illnesses, which strain health care systems. As chronic diseases become more prevalent with aging populations, effective and affordable drug therapies, such as biosimilars, are crucial for managing the disease burden efficiently in health care.

“Biosimilars contribute to the sustainability of health care systems, offering an attractive strategy to reduce costs and increase accessibility for patients, which can improve health outcomes. Furthermore, the introduction of biosimilars in the market not only increases competition but also encourages innovation, potentially stimulating advancements in the formulation and development of next-generation [biologic medicines],” wrote the authors.

Additionally, the European Medicines Agency declared all biosimilars as interchangeable with their reference products in September 2022, a policy that differs from that in the US, where biosimilars must obtain an extra approval to be deemed interchangeable at the pharmacy level.

The review was conducted using 3 databases (MEDLINE/PubMed, Web of Science, and ScienceDirect) to search for articles published in English between January 2006 and November 2023. The articles had to reference at least 1 European country, regardless of whether it was an EU member. Only studies regarding policy measures or instruments aimed at increasing biosimilar uptake were considered.

Of the 1137 articles found, 42 of which were duplicates, 13 were included in the final analysis. The included studies covered 28 European countries, including Austria, Belgium, Bulgaria, Croatia, Czechia (Czech Republic), Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

Three studies took a broad approach, encompassing multiple European countries, which offered a global perspective. Only 1 study simultaneously focused on 2 countries. The remaining 9 studies concentrating on individual countries. These studies discussed various policy measures and instruments implemented within each country to boost the biosimilars market share. Among these, 5 included real-world evidence investigations and highlighted specific policy measures or interventions utilized in their respective countries.

Of the 28 countries, 27 implemented pricing regulation measures, with tendering, price-linkage, and internal reference price being the most popular. Tendering alone was utilized by 27 countries. Tender systems function by having biosimilar and originator manufacturers compete directly on price in hopes of being chosen as the preferred product by the country’s public health plans. These systems level the playing field between biosimilars and their reference agents while ultimately lowering prices across the board.

Some countries adopted incentives for physicians, biosimilar quotas, and prescription by international nonproprietary name. Prescribing guidelines and recommendations were used by 17 countries. Automatic substitution policies were only used by 5 countries (Czechia, Estonia, France, Latvia, and Poland). The Netherlands, Norway, and Portugal were the only ones to utilize educational programs to encourage biosimilar adoption.

“Interchangeability is considered a determining factor in the adoption of biosimilars in the biological drugs market. Moreover, automatic substitution is an important issue in this context, as in most European countries, including Portugal, pharmacists cannot perform substitution without consulting the physician,” the authors noted.

The authors also emphasized that further research is needed to identify any additional policy measures and instruments that were not included in their analysis.

“Assessing the economic impact of policy measures and instruments on expenditures is crucial for understanding their significance. It is essential to determine whether the adopted policy measures and instruments have effectively met the intended objectives…. It is recommended that the [European Medicines Agency] provides guidance on the most effective policy measures and instruments to increase the biosimilars market share, with a focus on ensuring consistency and effectiveness across all European countries. This requires a thorough impact assessment of each measure and instrument,” they wrote.

Reference

Machado S, Cruz A, Ferreira PL, Morais C, Pimenta RE. Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review. Front Public Health. Published online February 28, 2024. doi:10.3389/fpubh.2024.1263472