14款仿制药通过一致性评价,来自正大天晴、福元医药…

2020-10-20 医药魔方 医药魔方

10月19日,国家药监局官网显示以下14款药品近日通过/视同通过一致性评价。其中,正大天晴卡培他滨片、四环制药加巴喷丁胶囊分别为国内第3家,福元医药瑞格列奈片、恒瑞医药盐酸普拉克索缓释片、仁合益康盐酸

10月19日,国家药监局官网显示以下14款药品近日通过/视同通过一致性评价。其中,正大天晴卡培他滨片、四环制药加巴喷丁胶囊分别为国内第3家,福元医药瑞格列奈片、恒瑞医药盐酸普拉克索缓释片、仁合益康盐酸西那卡塞片分别为国内第2家,赤峰万泽药业他克莫司软膏则为国内首家。

以下选取部分药物作一简单介绍:

卡培他滨片

卡培他滨是一种化疗药物,原研由罗氏开发,于1998年4月在美国获批,2001年3月,罗氏卡培他滨片在中国获批进口,商品名为希罗达。卡培他滨片为国家第三批集采药品,此前通过一致性评价的恒瑞和齐鲁制药均已中标。

瑞格列奈片

瑞格列奈是一种新型的非磺酰脲类短效口服促胰岛素分泌降糖药。该品种2017年国内销售额约11亿元,国内目前生产厂家有诺和诺德、北陆药业、福元医药、康瑞药业和豪森药业5家,但此前只有豪森药业通过一致性评价。

盐酸普拉克索缓释片

盐酸普拉克索缓释片是一种帕金森治疗药物,原研厂家为勃林格殷格翰。国内目前获批的普拉克索剂型主要为片剂和缓释片。其中,缓释片已经有京新药业率先获批,并视同通过一致性评价。

盐酸西那卡塞片

盐酸西那卡塞片主要用于治疗慢性肾脏病(CKD)维持性透析患者的继发性甲状旁腺功能亢进症,这是CKD患者常见的并发症,也是慢性肾衰竭终末期血液透析时最主要、最严重的并发症之一。4月15日,仟源医药子公司嘉逸药业的盐酸西那卡塞片首仿获得国家药监局批准,并视同通过一致性评价。仁合益康此次获批,为国内第2家该药获批厂家,视同通过一致性评价。

他克莫司软膏

他克莫司软膏主要用于治疗中重度特应性皮炎,该药此前国内生产厂家有7家,赤峰万泽药业他克莫司软膏按新4类批准上市,获批后视同通过一致性评价,为国内首家该药品过评厂家。

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 (4)
#插入话题
  1. [GetPortalCommentsPageByObjectIdResponse(id=1906953, encodeId=68e319069532a, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Fri Feb 12 12:26:09 CST 2021, time=2021-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261536, encodeId=833f1261536ff, 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=43, 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=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410072, encodeId=980a14100e2bf, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444656, encodeId=e37c144465612, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
    2021-02-12 zhanfl
  2. [GetPortalCommentsPageByObjectIdResponse(id=1906953, encodeId=68e319069532a, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Fri Feb 12 12:26:09 CST 2021, time=2021-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261536, encodeId=833f1261536ff, 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=43, 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=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410072, encodeId=980a14100e2bf, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444656, encodeId=e37c144465612, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
    2020-10-22 drwjr
  3. [GetPortalCommentsPageByObjectIdResponse(id=1906953, encodeId=68e319069532a, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Fri Feb 12 12:26:09 CST 2021, time=2021-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261536, encodeId=833f1261536ff, 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=43, 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=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410072, encodeId=980a14100e2bf, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444656, encodeId=e37c144465612, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
    2020-10-22 cathymary
  4. [GetPortalCommentsPageByObjectIdResponse(id=1906953, encodeId=68e319069532a, content=<a href='/topic/show?id=d91e1943441' target=_blank style='color:#2F92EE;'>#一致性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=19434, encryptionId=d91e1943441, topicName=一致性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3138208, createdName=zhanfl, createdTime=Fri Feb 12 12:26:09 CST 2021, time=2021-02-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1261536, encodeId=833f1261536ff, 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=43, 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=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410072, encodeId=980a14100e2bf, content=<a href='/topic/show?id=2c1c35262a9' target=_blank style='color:#2F92EE;'>#医药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=35262, encryptionId=2c1c35262a9, topicName=医药)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=36f62754598, createdName=cathymary, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1444656, encodeId=e37c144465612, content=<a href='/topic/show?id=3d9291459d1' target=_blank style='color:#2F92EE;'>#评价#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=21, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=91459, encryptionId=3d9291459d1, topicName=评价)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1fee5134542, createdName=huagfeg, createdTime=Thu Oct 22 08:26:09 CST 2020, time=2020-10-22, status=1, ipAttribution=)]
    2020-10-22 huagfeg

相关资讯

阿斯利康「替格瑞洛分散片」在中国获批上市

9月3日,阿斯利康在中国提交的抗血栓药物替格瑞洛分散片上市申请获得国家药监局批准。

在弓形虫病药物Daraprim价格上涨5000%后,FDA批准了其仿制药上市

美国食品药品监督管理局(FDA)批准Daraprim的首个仿制药。Daraprim用于治疗弓形虫病已达数十年历史,其价格曾在一夜之间从每片13.50美元飙升至750美元,并在2015年成为头条新闻。

药有不同,原研药与仿制药大解析

医学不断进步,科技不断发展,我国诊治重大型疾病的医疗水准越来越高,这其中,离不开药物研发脚步的不断加速。但与此同时,很多“门外汉”依然对治疗重大型疾病的药物了解匮乏。比如原研药与仿制药的区别,一直是各类科普文章离不开的话题。根据《中国仿制药蓝皮书》(2017版),2017年我国仿制药市场规模在整体药品市场规模中的占比维持在60%以上,由此可见,仿制药是我国医药市场的主导力量。过去,我国制药工业整体

吉利德:将在多国产销瑞德西韦,正与印巴药商谈判仿制药许可

当地时间5月5日,吉利德科学公司(Gilead Sciences)宣布,将与其他制药公司一起在美国以外的地区生产和销售新冠肺炎治疗药物瑞德西韦(remdesivir),以确保该药供应能满足全球需求。

FDA批准了默克Proventil HFA(硫酸沙丁胺醇)气雾剂的仿制药,用于儿童支气管痉挛

专员Stephen Hahn表示,FDA"认识到在新型冠状病毒大流行期间对沙丁胺醇产品的需求增加"。

辉瑞的美罗华仿制药RUXIENCE的营销申请,获得欧盟人用药物委员会的积极评价

辉瑞公司宣布,其美罗华(利妥昔单抗)的潜在的生物仿制药RUXIENCE的营销授权申请,获得欧洲药品管理局(EMA)的人用药品管理委员会(CHMP)的积极意见。