Samsung Bioepis Co. Ltd. and Organon & Co. announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab).

HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. HADLIMA was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018. The approval of citrate-free, high-concentration HADLIMA was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.

HADLIMA is expected to be launched on or after July 1, 2023 by Organon.