The FDA approved the citrate-free, high-concentration (100 mg/mL) formulation of adalimumab-bwwd (Hadlima, Samsung Bioepis), a biosimilar referencing Humira (adalimumab, AbbVie).
The approval provides a new option for the treatment of moderately to severely active Crohn’s disease in adults and children 6 years of age and older and for the treatment of moderately to severely active ulcerative colitis in adults.
Adalimumab-bwwd, a tumor necrosis factor (TNF), will be available in