12 月 14 日,联邦巡回上诉法院发布了一项决定,进一步明确了生物仿制药厂商披露产品信息的规则。具体而言,在 Amgen Inc. 诉 Sandoz Inc. 案中,联邦巡回上诉法院裁决,根据《生物制品价格竞争与创新法案》(BPCIA),生物制药原始提供者不能引用州法律强制那些申请生物仿制药上市的申请人披露有关产品的相关信息。
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