CHMP对Mylan和Biocon的曲妥珠单抗生物类似物Ogivri持积极意见

2018-10-21 MedSci MedSci原创

Mylan制药和Biocon制药近日宣布,欧洲药品管理局委员会人用药品(CHMP)发表了积极意见,建议批准Ogivri(罗氏曲妥珠单抗的生物类似物)。

Mylan制药和Biocon制药近日宣布,欧洲药品管理局委员会人用药品(CHMP)发表了积极意见,建议批准Ogivri(罗氏曲妥珠单抗的生物类似物)。CHMP的积极意见基于分析测试、临床前和临床研究中的相似性评估。这些结果表明,Ogivri和曲妥珠单抗在质量、有效性和安全性方面没有临床意义上的差异。此外,在转移性乳腺癌患者的III期临床研究(Heritage),Ogivri和曲妥珠单抗在安全性、有效性和免疫原性方面没有表现出临床意义上的差异,进一步加强了Ogivri与曲妥珠单抗具有高度相似性的结论。

Ogivri适用于治疗HER2阳性早期乳腺癌(EBC),转移性乳腺癌(MBC)和转移性癌(MGC)患者。在相关医疗保健专业人员的监督下,可以将其作为单一疗法或与依赖于相关诊断的其他药物组合处方。


原始出处:

http://www.firstwordpharma.com/node/1598582#axzz5UXJIsme7

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    2019-08-04 haouestc
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    2018-11-28 sunylz
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    2018-10-23 daviiliu
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    2018-10-23 医生2394