FDA advisory committee approval of first biosimilar leaves questions unanswered: Sandoz’s filgrastim faces naming and court hurdles

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FDA advisory committee approval of first biosimilar leaves questions unanswered: Sandoz’s filgrastim faces naming and court hurdles

机译：FDA咨询委员会对首个生物仿制药的批准使问题悬而未决：Sandoz的非格司亭面临命名和法庭障碍

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The unanimous vote in January by the Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee to recommend approval of the first biosimilar to be sold in the U.S. was hailed as momentous. Biosimilars are already sold widely in Europe, where they save consumers and governments billions of dollars.

机译：食品药品管理局（FDA）肿瘤药物咨询委员会于1月份一致投票建议批准在美国销售的首个生物仿制药，这一决定被认为是具有重大意义的。生物仿制药已经在欧洲广泛销售，为消费者和政府节省了数十亿美元。

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《P & T: a peer-reviewed journal for formulary management》 |2015年第3期|共1页
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FDA advisory committee approval of first biosimilar leaves questions unanswered: Sandoz’s filgrastim faces naming and court hurdles

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