On the 18th, Samsung Bioepis announced that the U.S. Food and Drug Administration (FDA) approved the high-concentration formulation of its Humira biosimilar, ‘Hadlima 100mg/mL’ on the 15th (local time).

The company plans to market the high-concentration Hadlima in the US market in July next year through its US marketing partner, Organon.

Hadlima is used for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. To improve patient convenience, the formulation will be offered to patients in a prefilled syringe (PFS) or autoinjector.

The approval of the citrate