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Alvotech Humira®高濃度生物仿製藥AVT02審批被拒
格隆匯4月14日丨美國FDA已經向梯瓦製藥(TEVA.US)的合作伙伴Alvotech(ALVO.US)發出Humira®高濃度生物仿製藥AVT02(阿達木單抗)生物製品許可申請的迴應信。回覆信指出,與Alvotech的生產設施有關的缺陷必須得到讓人滿意解決方案,因此該申請目前不被批准。AVT02是Humira(阿達木單抗)的高濃度生物仿製藥候選產品。在最近FDA的重新檢查之後,正在評估對細節的額外審查,以確定下一步的行動。然而,梯瓦製藥對管線中的其他化合物和AVT02的進一步進展仍持樂觀態度
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