FDA Approves High Concentration Hadlima

The FDA has approved a high-concentration (100 mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s Humira (adalimumab). Hadlima was developed by South Korea-based Samsung Bioepis and will be commercialized by Organon. It will be available in pre-filled syringe and autoinjector options when it launches July 1, 2023. The FDA had approved Hadlima in a low-concentration (50 mg/mL) formulation in July 2019.

“With this approval, we now have both a low and high concentration adalimumab biosimilar approved by the FDA, marking an important step towards expanding treatment options for patients suffering from certain chronic, autoimmune diseases,” Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a press release.

Outside the United States, the low concentration formulation of the biosimilar has been available since 2018. Hadlima is a tumor necrosis factor (TNF) blocker used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease and ankylosing spondylitis.

The FDA approval of high-concentration Hadlima was based on clinical data from a randomized, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of the two formulations in healthy volunteers.