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

Last week, Samsung Bioepis Co., Ltd. and Organon & Co. announced that the FDA accepted for review their supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar referencing HUMIRA (adalimumab). The FDA previously approved SB5 under the brand name HADLIMA as a low-concentration (50 mg/mL) formulation in July 2019. According to the press release, SB5 will be commercialized in the U.S. by Organon and is expected to launch in the U.S. on or after July 1, 2023, in accordance with a licensing agreement with AbbVie Inc.