目的:评估生物仿制药的加入对57个国家和地区8种生物制品定价的影响。
方法:我们利用中断的时间序列设计和IQVIAMIDAS®数据来分析八种生物制品的年度销售数据(阿达木单抗,贝伐单抗,epoetin,依那西普,filgrastim,英夫利昔单抗,pegfilgrastim,和曲妥珠单抗),从2012年1月1日至2019年12月31日,遍布57个国家和地区。我们研究了生物仿制药进入市场后,生物制剂前制造商定价的近期和长期变化。
结果:生物仿制药进入后,曲妥珠单抗的平均每剂生物制品价格立即降低了438美元,英夫利昔单抗112美元,贝伐单抗110美元.生物仿制药进入市场的持续影响导致每年每剂价格进一步下降:阿达木单抗49美元,290美元的Filgrastim,英夫利昔单抗21美元,曲妥珠单抗189美元.同样,我们分析了生物仿制药对美国四种生物制品价格的影响,三种生物制品的价格每年大幅下降,和Filgrastim一起,pegfilgrastim,英夫利昔单抗分别减少955美元、753美元和104美元。
结论:生物仿制药的引入显著降低了全球和美国的生物制品价格。这些发现不仅证明了增加生物仿制药利用的经济效益,但也强调了生物仿制药在控制医疗成本方面的重要性。政策应旨在扩大生物仿制药的可用性,以抵消因使用生物制剂而导致的医疗支出的指数增长。
OBJECTIVE: To evaluate the impact of the entry of biosimilars on the pricing of eight biologic products in 57 countries and regions.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.