Hyrimoz Approved as Biosimilar for Humira
October 31, 2018 – The U.S. FDA has approved Hyrimoz® (adalimumab-adaz), manufactured by Sandoz, as a biosimilar to AbbVie’s Humira® (adalimumab). It is the third Humira biosimilar to receive FDA approval, and is indicated to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.
In a clinical study, 67% of patients who had moderate to severe chronic plaque psoriasis and were treated with Hyrimoz saw a 75% improvement in their symptoms. Of patients treated with Humira, 65% saw the same level of improvement.
Recommended dosing with Hyrimoz varies by indication. A black box warning cautions that the product can increase a patient’s risk for serious infection, including tuberculosis, bacterial sepsis, invasive fungal
Infections, and other opportunistic infections, which can lead to hospitalization or death. The warning also cautions that lymphoma and other cancers have been reported in children and adolescents treated with TNF-blockers like adalimumab products. In addition, cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in adolescent and young adults with inflammatory bowel disease who were treated with TNF-blockers.
Hyrimoz is not expected to launch in the United States until 2023 due to a settlement reached between Sandoz and AbbVie following patent disputes. Pricing information is not available.