FDA Approves Humira Biosimilar to Treat Autoimmune Disorders

The U.S. Food and Drug Administration (FDA) has approved Samsung Bioepis’ Hadlima (adalimumab-bwwd) for the treatment of several autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease. FDA’s approval was specifically for a citrate-free, high-concentration version of Hadlima (adalimumab-bwwd). While FDA had already approved a low-concentration version of the medication, this new version will help provide an alternative for people who are prescribed Humira. According to rheumatologist Joseph R. Martinez, MD, “The FDA approval of Hadlima adds to the growing list of treatment options accessible to patients with certain autoimmune conditions. Patients can discuss this treatment option with their rheumatologist and decide if this is a good choice for them.”

The citrate-free component of this medication is one of the critical factors, ideally making this feature more available to consumers. “The citrate-free version of Humira has been effective in treating inflammatory symptoms of arthritis types without the side effects of the initial drug,” explained Nancy Mitchell, a registered nurse and contributing writer at Assisted Living. “Originally, senior patients taking Humira complained of experiencing discomfort, possibly due to the citrate buffer in the serum. The citrate worked to maintain optimum pH levels and, in turn, preserve the shelf life and viability of the drug. Some studies have shown a slight correlation between citrates in synovial fluid and inflammation in the joints.”

Samsung Bioepsis will begin preparing to launch Hadlima, which will take place in the United States on or after July 1, 2023, in accordance with a licensing agreement with AbbVie Inc., the maker of Humira (adalimumab).