Samsung Bioepis Co. Ltd. and Organon & Co. 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 40 mg/0.4 mL, a biosimilar to Humira® (adalimumab). The sBLA was submitted to the FDA by Samsung Bioepis in August 2023. The sBLA submission was based on clinical data from the Phase 4, randomized, double-blind, 1:1 ratio, parallel-group, multiple-dose, active comparator, multicenter clinical study (NCT05510063) to assess the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between high-concentration formulations of Humira and HADLIMA versus patients receiving Humira continuously.