生物相似药

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生物相似药在美国称为Biosimilars或是Follow-on biologics;欧盟称为Similar Biological Medicinal Products;台湾则称作生物相似药,是几乎和原药品相同,但由不同药厂制造的生物制剂。也就是原始创新药品的官方核可版本,当原厂的生物制剂专利到期后,其他药厂或生物科技公司可以参考该生物制剂的分子结构特性并利用已有数据,研发生产具有相似临床疗效的药物。
生物相似药
定义
生物相似药在美国称为Biosimilars或是Follow-on biologics;欧盟称为Similar Biological Medicinal Products;台湾则称作生物相似药,是几乎和原药品相同,但由不同药厂制造的生物制剂。也就是原始创新药品的官方核可版本,当原厂的生物制剂专利到期后,其他药厂或生物科技公司可以参考该生物制剂的分子结构特性并利用已有数据,研发生产具有相似临床疗效的药物。
生物相似药
生物相似药
生物相似药在美国称为Biosimilars或是Follow-on biologics;欧盟称为Similar Biological Medicinal Products;台湾则称作生物相似药,是几乎和原药品相同,但由不同药厂制造的生物制剂。也就是原始创新药品的官方核可版本,当原厂的生物制剂专利到期后,其他药厂或生物科技公司可以参考该生物制剂的分子结构特性并利用已有数据,研发生产具有相似临床疗效的药物。

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