Press "Enter" to skip to content

FDA Accepts Samsung Bioepis’ and Organon’s sBLA for their Citrate-Free, High-Concentration HUMIRA® (Adalimumab) Biosimilar Candidate

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 a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing HUMIRA® (adalimumab).[1] SB5 was previously approved by the FDA under the brand name HADLIMA™ as a low-concentration (50 mg/mL) formulation in July 2019. The low concentratio…

– 출처 :