Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) announced the FDA approval of 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 syringes and autoinjector options. The autoinjector was specifically designed with the patient in mind.
- Hadlima is the fourth FDA approved biosimilar to adlimumbad
- It is a tumor necrosis factor (TNF) blocker for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, and Ulcerative Colitis.
- Planned launch in the S. is in 2023