辉瑞的美罗华(利妥昔单抗)仿制药Ruxience,获得欧盟批准

2020-04-04 MedSci原创 MedSci原创

Ruxience被批准用于治疗非霍奇金淋巴瘤(NHL)、慢性淋巴细胞性白血病(CLL)、类风湿性关节炎(RA)、肉芽肿伴多血管炎(GPA)和显微多血管炎(MPA)和寻常型天疱疮(PV)。

辉瑞针对CD20单抗美罗华(利妥昔单抗,MabThera,rituximab)的生物仿制药Ruxience(rituximab),已获得欧盟批准。

此次批准允许将Ruxience用于治疗非霍奇金淋巴瘤(NHL)、慢性淋巴细胞性白血病(CLL)、类风湿性关节炎(RA)、肉芽肿伴多血管炎(GPA)和显微多血管炎(MPA)和寻常型天疱疮(PV)。

该决定是基于Ruxience与MabThera具有生物相似性的一系列数据,包括来自REFLECTIONS B3281006临床比较研究的结果,该研究评估了Ruxience的功效、安全性、免疫原性、药代动力学和药效学参数。数据显示Ruxience"在CD20阳性、低肿瘤负荷的滤泡性淋巴瘤患者中,与MabThera的安全或功效没有临床上有意义的差异。

辉瑞肿瘤学国际开发市场区域总裁Masum Hossain补充说:"像Ruxience这样的生物仿制药具有与原始产品相似的安全性和功效,可以显着降低医疗保健成本。"

原始出处:

http://www.pharmatimes.com/news/pfizer_wins_eu_approval_for_mabthera_biosimilar_1335582

版权声明:
本网站所有内容来源注明为“梅斯医学”或“MedSci原创”的文字、图片和音视频资料,版权均属于梅斯医学所有。非经授权,任何媒体、网站或个人不得转载,授权转载时须注明来源为“梅斯医学”。其它来源的文章系转载文章,或“梅斯号”自媒体发布的文章,仅系出于传递更多信息之目的,本站仅负责审核内容合规,其内容不代表本站立场,本站不负责内容的准确性和版权。如果存在侵权、或不希望被转载的媒体或个人可与我们联系,我们将立即进行删除处理。
在此留言
评论区 (5)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1793516, encodeId=feb41e93516b2, content=<a href='/topic/show?id=678315e47ba' target=_blank style='color:#2F92EE;'>#RUXIENCE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15747, encryptionId=678315e47ba, topicName=RUXIENCE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Mon Apr 06 20:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660486, encodeId=770a166048626, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Wed Jun 10 08:28:27 CST 2020, time=2020-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261529, encodeId=a51212615295f, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317165, encodeId=3ca1131e1651a, content=<a href='/topic/show?id=9181e99846e' target=_blank style='color:#2F92EE;'>#美罗华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79984, encryptionId=9181e99846e, topicName=美罗华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590021, encodeId=058915900210e, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=)]
    2020-04-06 howi
  2. [GetPortalCommentsPageByObjectIdResponse(id=1793516, encodeId=feb41e93516b2, content=<a href='/topic/show?id=678315e47ba' target=_blank style='color:#2F92EE;'>#RUXIENCE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15747, encryptionId=678315e47ba, topicName=RUXIENCE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Mon Apr 06 20:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660486, encodeId=770a166048626, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Wed Jun 10 08:28:27 CST 2020, time=2020-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261529, encodeId=a51212615295f, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317165, encodeId=3ca1131e1651a, content=<a href='/topic/show?id=9181e99846e' target=_blank style='color:#2F92EE;'>#美罗华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79984, encryptionId=9181e99846e, topicName=美罗华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590021, encodeId=058915900210e, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=)]
  3. [GetPortalCommentsPageByObjectIdResponse(id=1793516, encodeId=feb41e93516b2, content=<a href='/topic/show?id=678315e47ba' target=_blank style='color:#2F92EE;'>#RUXIENCE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15747, encryptionId=678315e47ba, topicName=RUXIENCE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Mon Apr 06 20:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660486, encodeId=770a166048626, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Wed Jun 10 08:28:27 CST 2020, time=2020-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261529, encodeId=a51212615295f, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317165, encodeId=3ca1131e1651a, content=<a href='/topic/show?id=9181e99846e' target=_blank style='color:#2F92EE;'>#美罗华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79984, encryptionId=9181e99846e, topicName=美罗华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590021, encodeId=058915900210e, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=)]
    2020-04-06 drwjr
  4. [GetPortalCommentsPageByObjectIdResponse(id=1793516, encodeId=feb41e93516b2, content=<a href='/topic/show?id=678315e47ba' target=_blank style='color:#2F92EE;'>#RUXIENCE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15747, encryptionId=678315e47ba, topicName=RUXIENCE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Mon Apr 06 20:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660486, encodeId=770a166048626, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Wed Jun 10 08:28:27 CST 2020, time=2020-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261529, encodeId=a51212615295f, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317165, encodeId=3ca1131e1651a, content=<a href='/topic/show?id=9181e99846e' target=_blank style='color:#2F92EE;'>#美罗华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79984, encryptionId=9181e99846e, topicName=美罗华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590021, encodeId=058915900210e, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1793516, encodeId=feb41e93516b2, content=<a href='/topic/show?id=678315e47ba' target=_blank style='color:#2F92EE;'>#RUXIENCE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=15747, encryptionId=678315e47ba, topicName=RUXIENCE)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Mon Apr 06 20:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1660486, encodeId=770a166048626, content=<a href='/topic/show?id=c0de32285a1' target=_blank style='color:#2F92EE;'>#利妥昔#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=32285, encryptionId=c0de32285a1, topicName=利妥昔)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a58d25117340, createdName=花花1374, createdTime=Wed Jun 10 08:28:27 CST 2020, time=2020-06-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261529, encodeId=a51212615295f, content=<a href='/topic/show?id=b56025592eb' target=_blank style='color:#2F92EE;'>#仿制药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=25592, encryptionId=b56025592eb, topicName=仿制药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=08e964, createdName=drwjr, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1317165, encodeId=3ca1131e1651a, content=<a href='/topic/show?id=9181e99846e' target=_blank style='color:#2F92EE;'>#美罗华#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=79984, encryptionId=9181e99846e, topicName=美罗华)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=37d0457, createdName=yhj-time, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590021, encodeId=058915900210e, content=<a href='/topic/show?id=2d1c63118e9' target=_blank style='color:#2F92EE;'>#欧盟批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63118, encryptionId=2d1c63118e9, topicName=欧盟批准)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0d617780998, createdName=chenwq14, createdTime=Mon Apr 06 13:28:27 CST 2020, time=2020-04-06, status=1, ipAttribution=)]

相关资讯

Blood:既往20余年结节性淋巴细胞为主型霍奇金淋巴瘤的治疗预后

以RT/CMT作为I-II期NLPHL患者的前期治疗或可提高患者的PFS。

Lancet:R-CHOP化疗联合利妥昔单抗治疗侵袭性B细胞非霍奇金淋巴瘤

研究认为,4轮R-CHOP化疗联合2轮利妥昔单抗治疗侵袭性B细胞非霍奇金淋巴瘤的效果与现行标准疗法相当

邱录贵教授:利妥昔单抗是淋巴瘤免疫化疗的“基石”药物,为惰性B细胞淋巴瘤带来显著生存获益丨2020年白血病·淋巴瘤高峰论坛

邱录贵教授编者按:2020年1月11~12日,“CSCO抗白血病联盟&抗淋巴瘤联盟工作会议暨2020年白血病·淋巴瘤高峰论坛”在美丽的沿海城市深圳市隆重召开,汇聚了国内外血液肿瘤的众多专家及学者,共同探讨白血病及淋巴瘤领域的诸多进展。利妥昔单抗(rituximab)是首个应用于肿瘤治疗的CD20单抗,在B细胞淋巴瘤的治疗中具有关键的价值,同时利妥昔单抗+CHOP方案也是弥漫大B细胞淋巴

英国NICE推荐将来那度胺与利妥昔单抗联合用于治疗滤泡性淋巴瘤

英国国家健康与护理卓越研究所(NICE)宣布推荐将Celgene的Revlimid(来那度胺)与Roche的MabThera(利妥昔单抗)组合用于先前已治疗过的滤泡性淋巴瘤患者,为大约900名患者提供了新的选择。

关于公开征求《利妥昔单抗注射液生物类似药临床试验指导原则(征求意见稿)》意见的通知

利妥昔单抗注射液由Genentech公司原研,2000年在中国上市,商品名为美罗华。目前,多家国内外制药企业加入其生物类似药的研发。为进一步明确技术审评标准,提高企业研发效率,在原国家食品药品监督管理

Cell Death Dis:新型HDAC抑制剂西达本胺可与利妥昔单抗协同抑制弥漫性大B细胞淋巴瘤

CD20缺失是复发性/难治愈性的弥漫性大B细胞淋巴瘤(DLBCL)采用利妥昔单抗相关方案再治疗的主要障碍。组蛋白去乙酰化会导致基因沉默,抑制CD20的表达。西达本胺(Chidamide)是组蛋白脱乙酰基酶(HDACs)的一种新型抑制剂。研究人员预测西达本胺可以预防利妥昔单抗介导的CD20表达下调并促进利妥昔单抗诱导的杀伤作用。本研究主要是通过构建内外源模型来研究西达本胺与利妥昔单抗在DLBCL中的