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三星Bioepis旗下贝伐单抗生物类似物AYBINTIO获CHMP正面评价

2020-06-28 Allan MedSci原创

韩国三星Bioepis公司近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)对AYBINTIO持肯定态度,该药品是贝伐单抗的生物类似物。

韩国三星Bioepis公司近日宣布,欧洲药品管理局(EMA)的人用药品委员会(CHMP)对AYBINTIO持肯定态度,该药品是贝伐单抗的生物类似物。CHMP推荐将AYBINTIO用于贝伐单抗的适应症,包括转移性结直肠癌(mCRC)、转移性乳腺癌(mBC)、非小细胞肺癌(NSCLC)、转移性肾细胞癌(mRCC)、上皮性卵巢癌、原发性腹膜癌和宫颈癌。欧盟委员会(EC)将对CHMP的积极意见进行审查,以决定是否授予AYBINTIO营销许可。

三星Bioepis临床科学高级副总裁Hee Kyung Kim表示:“高质量生物类似物是减轻患者经济负担的重要手段。一旦获得批准,AYBINTIO将成为针对不同类型癌症的有效治疗选择,可能会帮助欧洲的许多患者”。

AYBINTIO的市场授权申请书(MAA)得到了药代动力学(PK)和临床数据以及药理和毒理学数据的支持,这些数据表明AYBINTIO与贝伐单抗高度相似。此外,该公司于2019年9月提交了AYBINTIO的生物制剂许可申请(BLA),目前正在接受美国FDA的审查。

 

原始出处:

https://www.firstwordpharma.com/node/1735839?tsid=4

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    2021-02-05 hb2008ye
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    2020-07-06 gq1688888

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    2020-06-30 医生2394
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    2020-06-30 huagfeg
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