Europe’s Biosimilar Divide: New Study Reveals Which Policies Actually Drive Uptake

Biosimilar medicines were supposed to transform the economics of biologic therapies across Europe, offering cheaper alternatives to expensive originator drugs once patents expire. A decade and a half after the first wave of biosimilars entered the market, the promise is only partially fulfilled. Average biosimilar market shares across 27 European countries climbed from 3.6 percent in 2014 to 40.7 percent by mid-2024, according to a comprehensive new analysis published in The Lancet Regional Health – Europe. Yet behind that headline figure lies a striking patchwork: in Norway, Italy, Croatia, the United Kingdom and Finland, biosimilars now account for more than half of sales in their categories, while in Greece and Luxembourg uptake remains stuck below 10 percent. The study, conducted by the AUGMENT Consortium under commission from the European Commission’s EU4Health Programme, set out to answer a deceptively simple question: why do countries with access to the same approved products perform so differently?

The research team, led by Sabine Vogler of the Austrian National Public Health Institute, took an unusually broad approach. Previous studies of biosimilar policy typically examined a single country or a handful of biological substances. This analysis covered 27 European countries, including 24 European Union member states, Norway and Switzerland from the European Free Trade Association, and the United Kingdom, and spanned 27 biological active substances comprising roughly 200 individual products. The investigators drew on IQVIA MIDAS sales data covering the period from 2008 through the second quarter of 2024, capturing both hospital and community pharmacy settings for most countries. Cyprus, Denmark, Malta, Iceland and Liechtenstein had to be excluded because no data were recorded for them in the commercial database, a limitation the authors acknowledge, particularly given Denmark’s reputation as a biosimilar success story.

Quantitative analysis was only half the design. The team combined the sales data with a systematic mapping of national policies, compiled through standardised country fiches completed using information from the Pharmaceutical Pricing and Reimbursement Information network, a long-standing collaboration of public authorities responsible for medicine pricing across Europe. Twenty-one of the country fiches were validated by national officials, lending the policy mapping a degree of official confirmation that most cross-country comparisons lack. The researchers then layered on four detailed case studies, tracking market shares before and after specific interventions: switching guidance issued by Italy’s medicines agency, prescribing quotas for insulin glargine in France, and the introduction of pharmacy-level biosimilar substitution in Norway and France.

The policy taxonomy the researchers developed distinguishes supply-side measures, which shape prices and procurement, from demand-side measures, which target the behaviour of prescribers, pharmacists and patients. Supply-side tools include the biosimilar price link, in which a biosimilar’s price is set at a defined percentage below the originator’s; external price referencing, which borrows price benchmarks from other countries; competitive tendering, ubiquitous in hospital procurement; and horizon scanning to prepare payers for upcoming patent expiries. Demand-side tools range from prescribing by International Non-Proprietary Name and formal switching programmes to prescribing quotas, pharmacy substitution and gain-sharing models that return a portion of the savings generated by biosimilar use to hospitals or clinicians. Educational and awareness-raising activities, though present in every country studied, varied so widely in scope that the team excluded them from the comparative analysis.

The mapping revealed how saturated some policy instruments have become while others remain rare. Tendering is universal, applied in all 27 countries, particularly for hospital medicines. The biosimilar price link operates in 21 countries, and 18 countries include biologicals in their reference price systems for reimbursement. On the demand side, 24 countries now oblige, encourage or support prescribers to switch patients from originator biologics to biosimilars, or between biosimilars. Seventeen countries permit INN prescribing for biologicals and 15 impose prescribing quotas. By contrast, pharmacy-level substitution, long a staple of generic medicine policy, exists in only 11 countries, though momentum is building: Norway introduced it in 2021, France in 2022, and Finland, Germany and Switzerland all followed in 2024, typically starting with a narrow list of substances. Gain-sharing models, the study’s standout performer, remain confined to just ten countries.

When the researchers cross-referenced policies with market outcomes, a clear pattern emerged. Countries that had introduced gain-sharing models, encouraged switching, applied a biosimilar price link or imposed prescribing quotas showed, on average, the highest biosimilar market shares. Tendering and tendering-like procedures run by public payers in the outpatient sector were also associated with stronger uptake. The association with gain-sharing is particularly striking because the policy is so uncommon, implemented mainly in higher-income countries with large markets such as France, Germany and the United Kingdom. The authors are careful to stress that their cross-sectional comparison is exploratory and does not establish causation, but the case studies and the wider literature point in the same direction. In Italy, biosimilar market shares rose after the medicines agency published a position paper in March 2018 endorsing the interchangeability of biological medicines and supporting prescriber-initiated switches. In France, where quotas of 20 percent were set for insulin glargine in 2017 and raised to 40 percent in 2021, uptake of the targeted biosimilar increased. In Norway and France, the substances newly subject to pharmacy substitution, insulin glargine and teriparatide in the former and filgrastim and pegfilgrastim in the latter, saw rapid uptake gains after implementation.

The study’s systematic review of 16 empirical evaluations reinforced these findings. Prescribing quotas in Germany and Italy, gain-sharing experiments in France and Ireland, switching programmes in the United Kingdom and Denmark, and tendering systems in Hungary all increased biosimilar uptake in published analyses, with several also documenting substantial savings. One notable exception involved the biosimilar price link in Hungary, which reduced prices without lifting uptake, a reminder that lowering prices alone does not automatically change prescribing behaviour. The literature also emphasised the importance of policy design: gain-sharing works best when the clinical units that generate the savings are the ones that receive them, and price links must create a gap large enough to influence prescriber decisions.

Why do demand-side measures outperform? The authors argue that the principal barriers to biosimilar uptake are behavioural rather than economic. Physicians remain hesitant to switch clinically stable patients, citing lingering concerns about immunogenicity and equivalence, while patients harbour their own fears about safety. Policies that directly address these reservations, through clear regulatory guidance, financial incentives that reward prescribers, and credible communication, appear to provide the leverage that price mechanisms alone cannot. The Norwegian experience with the NOR-SWITCH trial is instructive: prescribing of infliximab biosimilars increased even before the landmark switching study was officially published, once draft findings confirming the safety of the switch circulated informally. The authors suggest that, given the accumulated real-world evidence on switching safety, improving communication should now take priority over commissioning yet more switching studies.

The findings arrive at a critical moment. A next wave of biosimilars is expected to enter European markets in the coming years, challenging some of the highest-priced originator biologics, and the untapped potential identified in low-uptake countries represents billions in possible savings. The study’s message to policymakers is twofold. First, effective interventions usually combine measures, ideally pairing demand-side drivers with supply-side tools such as strategic procurement that considers more than price alone and guards against markets becoming unattractive to suppliers. Second, design and context matter: the same policy instrument can succeed or fail depending on how it is calibrated, how stakeholders are engaged, and how it interacts with other measures already in place. The authors call for continuous monitoring and evaluation as countries implement and refine their policies, noting that even pharmacy substitution, too recent in several countries to show measurable population-level effects, showed promising early signals in the case studies. For a continent united by a single medicines regulator but divided by a fourfold gap in biosimilar uptake, the lesson is that approval was never the hard part; policy is.

Subject of Research: Policy analysis of biosimilar uptake and market shares across 27 European countries

Article Title: Biosimilar uptake policies in Europe: a cross-country mixed-methods policy analysis

Article References: Vogler, S., Habimana, K., Walter, M., Knoll, V., Kuriata, E., Leoszkiewicz, K., Mucha, K., Pelczarska, A., Skassa, E., Petrova, G., Milushewa, P., Mitkova, Z., Tachkov, K., Perelman, J., Alves, J., Santos, C., & Vasconcelos, H. (2026). Biosimilar uptake policies in Europe: a cross-country mixed-methods policy analysis. The Lancet Regional Health – Europe, 70, Article 101868. https://doi.org/10.1016/j.lanepe.2026.101868

Image Credits: AI Generated

DOI: 10.1016/j.lanepe.2026.101868

Keywords: biosimilars, pharmaceutical policy, drug pricing, Europe, market share, tendering, prescribing quotas, gain-sharing, switching, pharmacy substitution, health economics, The Lancet Regional Health