Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, United States of America.
Department of Maternal and Child Health, UNC Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States of America.
PLoS One. 2024 Jun 6;19(6):e0304851. doi: 10.1371/journal.pone.0304851. eCollection 2024.
To evaluate the impact of the entry of biosimilars on the pricing of eight biologic products in 57 countries and regions.
We utilized an interrupted time series design and IQVIA MIDAS® data to analyze the annual sales data of eight biologic products (adalimumab, bevacizumab, epoetin, etanercept, filgrastim, infliximab, pegfilgrastim, and trastuzumab) across 57 countries and regions from January 1, 2012, to December 31, 2019. We examined the immediate and long-term changes in biologics ex-manufacturer pricing following the entry of biosimilars to the market.
Following the entry of biosimilars, the average price per dose of biologic product was immediately reduced by $438 for trastuzumab, $112 for infliximab, and $110 for bevacizumab. The persistent effect of biosimilars' market entry led to further reductions in price per dose every year: by $49 for adalimumab, $290 for filgrastim, $21 for infliximab, and $189 for trastuzumab. Similarly, we analyzed the impact of biosimilars on four biologics' prices in the US, where the prices of three biologics significantly decreased every year, with filgrastim, pegfilgrastim, and infliximab decreasing by $955, $753, and $104, respectively.
The introduction of biosimilars has significantly reduced the prices of biologics both globally and in the US. These findings not only demonstrate the economic benefits of increasing biosimilar utilization, but also emphasize the importance of biosimilars in controlling healthcare costs. Policies should aim to expand the availability of biosimilars to counteract the exponential growth of medical spending caused by the use of biologics.
评估生物类似药进入市场对 57 个国家和地区的 8 种生物制品定价的影响。
我们采用中断时间序列设计和 IQVIA MIDAS®数据，分析了 2012 年 1 月 1 日至 2019 年 12 月 31 日 57 个国家和地区的 8 种生物制品（阿达木单抗、贝伐珠单抗、依泊汀、依那西普、非格司亭、英夫利昔单抗、培非格司亭和曲妥珠单抗）的年销售数据。我们考察了生物类似药进入市场后生物制剂出厂价的即时和长期变化。
生物类似药进入市场后，曲妥珠单抗、英夫利昔单抗和贝伐珠单抗的每支剂量平均价格立即降低了 438 美元、112 美元和 110 美元。生物类似药市场进入的持续影响导致每支剂量的价格每年进一步降低：阿达木单抗降低 49 美元、非格司亭降低 290 美元、英夫利昔单抗降低 21 美元、曲妥珠单抗降低 189 美元。同样，我们分析了生物类似药对美国四种生物制品价格的影响，其中三种生物制品的价格每年都显著下降，非格司亭、培非格司亭和英夫利昔单抗的价格分别下降了 955 美元、753 美元和 104 美元。
生物类似药的引入显著降低了全球和美国生物制品的价格。这些发现不仅证明了增加生物类似药使用的经济效益，还强调了生物类似药在控制医疗保健成本方面的重要性。政策应旨在扩大生物类似药的供应，以应对因使用生物制品而导致的医疗支出的指数级增长。
