Morolla Davide, Beran David, Ewen Margaret, Raviglione Mario, von Schoen-Angerer Tido
Centre for Multidisciplinary Research in Health Science, University of Milan, Milan, Italy
Department of Cardiology, Antonio Perrino Hospital, Brindisi, Italy.
BMJ Open. 2025 Jan 30;15(1):e090484. doi: 10.1136/bmjopen-2024-090484.
Quantify insulin glargine prices following the market introduction of biosimilars. Examine price levels and price changes for originator and biosimilars, by country.
Retrospective quantitative analysis using insulin glargine pricing data, both of the originator product and its biosimilars. Segmented regression analysis using a dual-model approach: pooled and country-specific.
28 European countries using data from the European Medicine Price Database for the period 2013-2023.
Price variations between countries were analysed to assess trends and correlations before and after biosimilar market entry.
In the 28 countries studied, cost of insulin glargine underwent a median 21.6% decrease overall in the last decade (p<0.001). In 2022, the median price was €9.0 for the originator (first to market) Lantus (IQR €8.1-€10.4), €8.9 for the biosimilar Abasaglar (IQR €7.6-€10.1) and €7.0 for the biosimilar Semglee (median €7.0; IQR €6.8-€7.5). The originator price was higher than biosimilars (p=0.009). Biosimilar market entry was associated with an overall significant price reduction of the originator, both immediately after entry (p<0.001) and in the long-term postentry (p<0.001). No significant correlation was observed between the price of insulin and the countries' economic indicators.
This is the first study to show the price trend of insulin glargine and its correlation with the introduction of biosimilars, in Europe. A significant price reduction of the originator was observed after biosimilars entered the market. The median cost of biosimilars was lower than the originator, although with substantial differences between individual countries and producers.
在生物类似药进入市场后对甘精胰岛素的价格进行量化。按国家研究原研药和生物类似药的价格水平及价格变化。
使用甘精胰岛素原研产品及其生物类似药的定价数据进行回顾性定量分析。采用双模型方法进行分段回归分析:汇总模型和特定国家模型。
利用2013年至2023年期间欧洲药品价格数据库的数据,涉及28个欧洲国家。
分析各国之间的价格差异,以评估生物类似药进入市场前后的趋势和相关性。
在研究的28个国家中,甘精胰岛素的成本在过去十年中总体中位数下降了21.6%(p<0.001)。2022年,原研药(首个上市)来得时(Lantus)的中位数价格为9.0欧元(四分位间距8.1 - 10.4欧元),生物类似药阿必鲁泰(Abasaglar)为8.9欧元(四分位间距7.6 - 10.1欧元),生物类似药赛姆优泌(Semglee)为7.0欧元(中位数7.0欧元;四分位间距6.8 - 7.5欧元)。原研药价格高于生物类似药(p = 0.009)。生物类似药进入市场与原研药立即(p<0.001)及长期(p<0.001)的总体显著降价相关。未观察到胰岛素价格与各国经济指标之间存在显著相关性。
这是第一项展示欧洲甘精胰岛素价格趋势及其与生物类似药引入相关性的研究。生物类似药进入市场后观察到原研药显著降价。生物类似药的中位数成本低于原研药,尽管各国和各生产商之间存在很大差异。