Samsung Bioepis & Organon Announce FDA Acceptance Of Supplemental Biologics License Application For Interchangeability Designation For HADLIMA, A Biosimilar To Humira
Samsung Bioepis & Organon Announce FDA Acceptance Of Supplemental Biologics License Application For Interchangeability Designation For HADLIMA, A Biosimilar To Humira
三星 Bioepis & Organon 宣布美国食品药品管理局接受 Humira 的生物仿制药 HADLIMA 的可互换性认证的补充生物制剂许可申请
sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued group
Filing acceptance reinforces Samsung Bioepis and Organon's commitment to provide better access to biologic medicines for patients in the United States
sbLA 基于 4 期研究，该研究评估了两个治疗组之间的药代动力学相似性：在 Humira 和高浓度 HADLIMA 之间交替使用多切换组 vs Humira持续组
申请受理强化了三星Bioepis和Organon为美国患者提供更好获得生物药物的承诺
INCHEON, South Korea and JERSEY CITY, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE:OGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental Biologics License Application (sBLA) for the interchangeability designation for HADLIMA (adalimumab-bwwd) injection...
韩国仁川和新泽西州泽西城，2023 年 11 月 7 日（GLOBE NEWSWIRE）——三星 Bi...
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