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监管和市场力量推动生物类似药采用的证据。

Evidence That Regulatory And Market Forces Are Driving Adoption Of Biosimilars.

机构信息

Janice Jhang (

Troyen A. Brennan, Harvard University.

出版信息

Health Aff (Millwood). 2024 Nov;43(11):1553-1560. doi: 10.1377/hlthaff.2024.00366.

Abstract

Biosimilars present a key opportunity to contain the growing cost of biologic drug spending and to make essential medications more affordable. However, the lackluster performance of the US biosimilar market in its first decade was met with disappointment and concern for its future viability. To evaluate the evolution of the biosimilar market, we reviewed key distinctions in medication classes and the financial stakeholders involved in each. Within this context, we examined recent evidence that suggests that the maturing postapproval biosimilar marketplace is flourishing. The entry of biosimilars for adalimumab offers a case study demonstrating these recent market and policy dynamics. Building on recent gains, policy makers could take additional steps to accelerate biosimilar adoption through both payment and regulatory policy levers.

摘要

生物类似药为控制生物药物支出的不断增长和降低基本药物的价格提供了一个重要的机会。然而,美国生物类似药市场在其第一个十年中的表现不佳,令人失望,并对其未来的生存能力表示担忧。为了评估生物类似药市场的演变,我们回顾了药物类别中的关键区别以及每个类别所涉及的财务利益相关者。在这种背景下,我们研究了最近的证据,这些证据表明,日益成熟的生物类似药批准后市场正在蓬勃发展。阿达木单抗生物类似药的进入为这些近期的市场和政策动态提供了一个案例研究。在最近取得的成果的基础上,政策制定者可以通过支付和监管政策杠杆采取更多措施来加速生物类似药的采用。

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