Biosimilars Fuel Price Cuts in European Insulin Glargine Markets

Although originator insulin glargine (Lantus) continues to be the leading insulin glargine product prescribed globally, its price has significantly been impacted by biosimilar competition, according to a review of 28 European countries.^1,2

Authors of the review, published in BMJ Open, sought to quantify insulin glargine prices following market introduction of biosimilars, assessing access and pricing differences across European Union member states.¹

There are 2 insulin glargine biosimilars approved in the Eurupean Union. | Image credit: koya979 - stock.adobe.com

Biological medicines account for 35% of Europe’s pharmaceutical spending, with costs threatening health care sustainability and access. Europe’s biologics market, the second-largest in the world, was valued at $57 billion in 2021 and is expected to reach $85 billion by 2030. Insulin, a life-saving treatment for diabetes, is among the most widely used biologics, with 71 million people worldwide relying on it.

The global insulin market is dominated by Novo Nordisk, Eli Lilly, and Sanofi, controlling 99% by value and 96% by volume. Market growth—from $2 billion in 1995 to $36 billion in 2020—has kept insulin prices high. In low- to middle-income countries, insulin costs are often unaffordable, whereas in Europe, government-funded insurance helps ease the financial burden on individuals.

As of January 2025, the European Medicines Agency has approved 2 insulin glargine biosimilars: Vitaris and Biocon Biologics’ Semglee and Eli Lilly’s Abasaglar, known as Basaglar in the US.³ Lantus is the current leader of the long-acting insulin market, remaining strong with over 39.6% share, followed by Levemir (insulin detemir), according to data from Report Linker.² Newer insulin glargine options like Toujeo, Tresiba, and Basaglar are available in only a few countries but have gained strong traction where launched.

Utilization growth for insulin glargine biosimilars has varied across individual European countries, according to a 2021 review of long-acting insulin use in African, Asian, European, and South American countries.⁴ Poland experienced the highest increase in long-acting insulin analogue use (210.6%) since the biosimilar market introduction, driven by flat reimbursement policies and biosimilar promotion efforts, whereas Slovenia saw the smallest utilization change (10.7%). Although use has varied, evaluations to see whether insulin glargine biosimilars are delivering on price reductions are needed.¹

The present study was a retrospective, quantitative, longitudinal analysis examining insulin glargine price changes across 28 European countries from 2013 to 2023.¹ Pricing data for both the originator product and biosimilars were obtained from the European Medicine Price Database, a voluntary, nonprofit cooperation among national authorities.

The researchers employed segmented regression analysis using a pooled and country-specific dual-model approach to assess trends in price variations before and after biosimilar market entry. The data set included publicly reimbursed medicine prices from 28 European countries, excluding Germany, Malta, and Luxembourg. The study aimed to quantify price reductions following biosimilar introduction and analyze correlations with national economic indicators.

By 2015, Abasaglar was available in 89% of the countries studied; Semglee entered 32% of markets by 2019. Of the countries analyzed, 7% had no biosimilars, 64% had only 1, and 25% had 2 biosimilars in the market.

Over the 10-year period, the median price of Lantus dropped by 21.6%, with reductions varying between countries. For example, Italy saw a decrease of only 4.8%, whereas Latvia experienced a significant 42.3% drop. The entry of Abasaglar led to an immediate and significant reduction in the price of Lantus (P < .001), followed by a continued decline over time. In countries where only 1 biosimilar was marketed, the price of Lantus dropped by 22.2%, whereas in countries with 2 biosimilars, it decreased by 21%. These reductions were not significantly different between the 2 groups.

Regarding pricing comparisons, the median price of Lantus was €9.0, higher than the median biosimilar prices (Abasaglar, €8.9; Semglee, €7.0). However, there were significant price differences between countries and between the different biosimilars.

In countries where Abasaglar entered the market, there was an immediate average price reduction of 0.842 units, and prices continued to decrease at a rate of 0.054 units each quarter (P < .001). Country-specific factors such as initial market conditions and regulatory frameworks contributed to the wide variability in pricing across the countries studied.

Although most countries experienced long-term price reductions following biosimilar entry, some countries, including Switzerland and Denmark, saw temporary price increases or price fluctuations. A deeper analysis of the price trends in select countries showed that in some, such as Croatia and the Czech Republic, prices fluctuated over time without a consistent downward trend, whereas in others like Denmark and Portugal, prices decreased over time, sometimes in response to the entry of a second biosimilar.

Finally, the study found no statistically significant correlation between the price of Lantus and economic indicators such as gross domestic product (GDP), health expenditure as a share of GDP, or health expenditure per capita. Because of this, the authors reasoned that broader economic factors did not significantly influence the pricing trends of insulin glargine in the studied markets.

References

1. Morolla D, Beren D, Ewen M, Raviglione M, von Schoen-Angerer T. Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries. BMJ Open. 2025;15(1):e090484. doi:10.1136/bmjopen-2024-090484.

2. Insulin glargine market size & share analysis - growth trends & forecasts (2023 - 2028). Press release. Report Linker. August 18, 2023. Accessed February 13, 2025. https://www.globenewswire.com/news-release/2023/08/18/2727840/0/en/Insulin-Glargine-Market-Size-Share-Analysis-Growth-Trends-Forecasts-2023-2028.html

3. Biosimilar approvals. The Center for Biosimilars^®. Updated January 7, 2025. Accessed February 13, 2025. https://www.centerforbiosimilars.com/biosimilar-approvals

4. Godman B, Haque M, Leong T, et al. The current situation regarding long-acting insulin analogues including biosimilars among African, Asian, European, and South American countries; findings and implications for the future. Front Public Health. 2021;9:671961. doi:10.3389/fpubh.2021.671961