辉瑞生物仿制药Nivestym获FDA批准用于治疗中性粒细胞减少症

2018-07-23 MedSci MedSci原创

辉瑞公司近日宣布,其公司的生物仿制药Nivestym已获得美国食品和药物管理局(FDA)的批准,可用于安进公司的Neupogen(非格司亭)的所有适应症。

辉瑞公司近日宣布,其公司的生物仿制药Nivestym已获得美国食品和药物监督管理局(FDA)的批准,用于治疗安进公司Neupogen(非格司亭)的所有适应症。

Neupogen(重组人粒细胞集落刺激因子)曾经是安进公司的超级重磅药物,最初于1991年获得FDA批准上市,其核心专利早已在2006年到期。诺华公司的Zarxio是Neupogen的第一个生物仿制药,于2015年3月获得FDA的批准上市。

目前,辉瑞Nivestym的获批主要是是基于对综合试验数据的审查,试验证明Nivestym与其参考产品相比具有高度相似性。Nivestym在美国可用于于5种情况的中性粒细胞减少症,包括:接受骨髓抑制剂进行化疗的癌症患者、接受诱导化疗或巩固化疗的急性髓性白血病(AML)患者、经历骨髓移植的癌症患者、经历自体外周血干细胞采集和治疗患者、以及严重慢性嗜中性粒细胞减少症患者。

美国健康事业部负责人Berk Gurdogan指出:"FDA对Nivestym批准,标志着扩大中性粒细胞减少症患者对关键药品获取中的非常关键的一步,其中很多癌症患者因化疗引起的危及生命的副作用住院。我们相信生物仿制药Nivestym,对于帮助满足不断变化的医疗保健需求至关重要,并可能为患者提供更实惠的药物。"

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    2019-02-27 tamgche
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  5. 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  6. 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content=<a href='/topic/show?id=a3996918811' target=_blank style='color:#2F92EE;'>#生物仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69188, encryptionId=a3996918811, topicName=生物仿制药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=cfb42911806, createdName=grace5701, createdTime=Wed Jul 25 13:02:00 CST 2018, time=2018-07-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=333677, encodeId=94543336e7c5, content=学习了,谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Mon Jul 23 22:32:35 CST 2018, time=2018-07-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=333676, encodeId=dd703336e64f, content=学习了,长知识, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220115/46bcf39c32de4aa6b45c5f9d66c8ee77/6cb4a20c55bb4b7691122f47747bfca2.jpg, createdBy=9dad1662329, createdName=1ddf0692m34(暂无匿称), createdTime=Mon Jul 23 22:32:30 CST 2018, time=2018-07-23, status=1, ipAttribution=)]
    2018-07-25 drwjr
  7. 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  9. 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    2018-07-23 1209e435m98(暂无昵称)

    学习了,谢谢分享

    0

  10. 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    2018-07-23 1ddf0692m34(暂无匿称)

    学习了,长知识

    0

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