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美国的生物类似药和后续产品:采用、价格和使用者。

Biosimilars And Follow-On Products In The United States: Adoption, Prices, And Users.

机构信息

Ariel Dora Stern (

Jacqueline L. Chen is a research assistant in the Technology and Operations Management Unit, Harvard Business School.

出版信息

Health Aff (Millwood). 2021 Jun;40(6):989-999. doi: 10.1377/hlthaff.2020.02239.

Abstract

Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the US and worldwide. Against this backdrop, many look to the expanding market for biosimilars-follow-on products to biologic drugs-as a vehicle for controlling pharmaceutical spending. This study explores the early years of entry of biosimilars and related follow-on products in the US. Using monthly sales data from the period 2005-19 for ten drug classes, we examine how quickly biosimilars/follow-on products gained market share and the subsequent trajectory of prevailing (national average invoice) prices. Our analysis suggests that although uptake has been slower than what is typically seen in generic drug markets, the most recent entrants have captured market share more rapidly than comparable earlier biosimilars/follow-on products. We also document that from biosimilar/follow-on products' time of entry, their lower prices help offset the overall trend in average annual reference-product price increases. Our findings can provide insight into future policy reforms aimed at increasing competition and use of biosimilars, leading to expanded patient access and significant cost savings.

摘要

生物类似药在药品支出的增长中占了不成比例的份额,无论是在美国还是在全球皆是如此。有鉴于此,许多人将生物类似药(生物药的后续产品)不断扩大的市场视为控制药品支出的一种手段。本研究探讨了生物类似药及其相关后续产品在美国的早期进入情况。我们使用了 2005 年至 2019 年期间十个药物类别每月的销售数据,研究了生物类似药/后续产品的市场份额增长速度以及随后的主导(全国平均发票)价格轨迹。我们的分析表明,尽管采用速度比通常在仿制药市场中看到的要慢,但最近进入市场的产品比早期的生物类似药/后续产品更快地占据了市场份额。我们还记录到,从生物类似药/后续产品进入市场的时间来看,它们的低价有助于抵消参考产品平均年度价格上涨的总体趋势。我们的研究结果可以为未来旨在增加竞争和使用生物类似药的政策改革提供参考,从而扩大患者的可及性并节省大量成本。

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