FDA Approves Humira Biosimilar Hyrimoz for Treatment of IBD, Other Conditions

FDA Approves Humira Biosimilar Hyrimoz for Treatment of IBD, Other Conditions
The U.S. Food and Drug Administration (FDA) approved Hyrimoz (adalimumab-adaz, by Sandoz), a biosimilar to AbbVie’s Humira (adalimumab) for the treatment of Crohn’s disease (CD) in adults and ulcerative colitis (UC). A biosimilar is a therapeutic that has similar active properties to an original product. “Biosimilars can help people suffering from chronic, debilitating conditions gain expanded access to important medicines that may change the outcome of their disease,” Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said in a press release. Hyrimoz is the third approved biosimilar therapy by Sandoz in the U.S. The company plans to launch additional biosimilars for oncology and immunology indications by 2020. Last month, Sandoz and AbbVie reached a global resolution of intellectual property-related litigation related to Hyrimoz. The license allows U.S. patients to access Hyrimoz as of Sept. 30, 2023. Adalimumab is an injectable therapeutic that blocks tumor necrosis factor (TNF)-alpha — a pro-inflammatory protein involved in diverse cellular processes, such as cell survival, proliferation, differentiation, and death. TNF-alpha is produced at excessive levels in CD, UC and other autoimmune conditions, lead
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