The Supreme Court Ruling in Sandoz v Amgen,JAMA Internal Medicine

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The Supreme Court Ruling in Sandoz v Amgen
JAMA Internal Medicine ( IF 22.5 ) Pub Date : 2018-01-01 , DOI: 10.1001/jamainternmed.2017.6145
Ameet Sarpatwari ₁ , Abbe R. Gluck ₂ , Gregory D. Curfman _{2,

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Affiliation

In June 2017, the Supreme Court issued its first decision concerning follow-on biologics—lower-cost versions of innovator biologics—ruling 9-0 in Sandoz v Amgen.1 The decision ruled that follow-on biologic companies are not required to share their licensing application with the innovator company and that a required 180day notice to the innovator company before commercial marketing could be given before US Food and Drug Administration (FDA) approval of their product. This handed the nascent follow-on biologics industry a substantial, albeit incomplete victory, which may help reduce prices and improve patient access to biologic therapies.

中文翻译：

最高法院在 Sandoz 诉 Amgen 案中的裁决

2017 年 6 月，最高法院在 Sandoz 诉 Amgen 案中以 9-0 的比分裁定了后续生物制剂（创新生物制剂的低成本版本）的第一个裁决。向创新公司提出许可申请，并且在美国食品和药物管理局 (FDA) 批准其产品之前，必须提前 180 天通知创新公司，然后才能进行商业营销。这为新生的后续生物制品行业带来了实质性的、尽管不完全的胜利，这可能有助于降低价格并改善患者获得生物疗法的机会。

更新日期：2018-01-01

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