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3款注射剂获批,视同通过一致性评价

2020-10-10 风丘 医药魔方

10月9日,3款注射剂获国家药监局批准上市并视同通过一致性评价,分别是:江苏盈科生物制药的丙泊酚中/长链脂肪乳注射液、普利制药的注射用比伐芦定和江苏杜瑞制药的注射用甲磺酸萘莫司他。

10月9日,3款注射剂获国家药监局批准上市并视同通过一致性评价,分别是:江苏盈科生物制药的丙泊酚中/长链脂肪乳注射液、普利制药的注射用比伐芦定和江苏杜瑞制药的注射用甲磺酸萘莫司他。

丙泊酚中/长链脂肪乳注射液是一种短效、全身用麻醉剂,被广泛应用于围手术期的麻醉诱导、麻醉维持,以及ICU病房的镇静。该品种国内目前有4家企业获批,市场份额大约为20亿元,市场格局主要以原研厂家费森尤斯卡比为主。

丙泊酚中/长链脂肪乳注射液是目前注射剂申报一致性评价的热门品种,共有9家企业申报一致性评价,其中包括首仿厂家嘉博制药。江苏盈科生物制药于2019年4月按4类提交该药上市申请,今日获批上市并视同通过一致性评价,成为国内首家过评企业。

注射用比伐芦定

比伐芦定是一种人工合成的抗凝血药物,其注射剂由The Medicine Company研发,于2000年12月获FDA批准上市。普利制药注射用比伐芦定属于共线产品,于2019年7月按4类仿制药在中国提交上市申请,2020年1月以「同一生产线生产,已在欧盟国家上市」为由纳入优先审评程序。

国内目前生产销售注射用比伐芦定企业众多,其中,齐鲁制药已于2020年1月首家通过一致性评价。普利制药成为该品种第2家通过一致性评价的企业,剩余的双成药业、豪森药业、昂彪制药、信立泰、上海上药第一生化药业几家公司仍处于一致性评价申请当中。

注射用甲磺酸萘莫司他

甲磺酸萘莫斯他为合成的蛋白酶抑制剂,由日本Tobacco公司研发,临床上主要用于治疗胰腺炎以及弥散性血管内凝血(DIC)等。该药原研目前并未在中国申报,江苏杜瑞制药于2017年6月按3类在中国提交首家上市申请,今日获批上市则成为国内首仿。

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    2020-10-28 zhanfl
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    2020-10-13 Lexi

    该药原研目前并未在中国申报,江苏杜瑞制药于2017年6月按3类在中国提交首家上市申请,今日获批上市则成为国内首仿。

    0

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    2020-10-12 jacob9231

    学习啦赞赞赞

    0

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    2020-10-12 zchen
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    2020-10-12 huagfeg

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