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 宣佈美國食品藥品管理局接受 Humira 的生物仿製藥 HADLIMA 的可互換性認證的補充生物製劑許可申請
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 基於 4 期研究，該研究評估了兩個治療組之間的藥代動力學相似性：在 Humira 和高濃度 HADLIMA 之間交替使用多切換組 vs Humira持續組
申請受理強化了三星Bioepis和Organon爲美國患者提供更好獲得生物藥物的承諾
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...
韓國仁川和新澤西州澤西城，2023 年 11 月 7 日（GLOBE NEWSWIRE）——三星 Bi...
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