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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

2020-03-26 CDE CDE

利妥昔单抗生物类似药
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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

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总局已发布的《生物类似药研发与评价技术指导原则（试行）》基础上，结合利妥昔单抗的特点，药品审评中心组织起草了《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）》，以期为国内利妥昔单抗生物类似药的临床研发提供参考。
       我们诚挚地欢迎社会各界对征求意见稿提出宝贵意见和建议，并及时反馈给我们，以便后续完善。征求意见时限为自发布之日起1个月。
       您的反馈意见请发到以下联系人的邮箱：
       联系人：唐凌，齐玥丽
       联系方式：tangl@cde.org.cn，qiyl@cde.org.cn
       感谢您的参与和大力支持。

附件 1 ： 利妥昔单抗注射液生物类似药临床试验指导原则.docx

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    2020-10-05 zhaohui6731

    #征求意见#

    0

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    2020-05-05 ms2999106592497887

    #单抗注射液#

    0

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    2020-09-02 花花1374

    #利妥昔#

    0

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    2020-11-09 smlt2008

    #征求意见稿#

    0

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    2020-03-28 yyj062

    #生物类似药#

    0

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    2020-03-28 shijzhiewnjhch

    #注射液#

    0

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