Alvotech公布其恩利优®(Entyvio®)拟议生物类似药关键药代动力学研究的积极顶线结果

美股速递
Feb 05

生物制药公司Alvotech近日宣布,其针对参考药物恩利优®(Entyvio®)开发的拟议生物类似药,在一项关键性药代动力学研究中取得了积极的顶线结果。该研究旨在评估候选生物类似药与参照药在健康受试者体内的药代动力学相似性。初步数据显示,研究达到了其主要终点,证明了两者在关键药代动力学参数上具有生物等效性。这一积极进展标志着Alvotech在该生物类似药的研发道路上迈出了重要一步,为其后续向监管机构提交上市申请奠定了坚实基础。

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