Hulio, Humira Biosimilar, Gets FDA Nod for Crohn’s, UC, But Not Available Until 2023

Hulio, Humira Biosimilar, Gets FDA Nod for Crohn’s, UC, But Not Available Until 2023
The U.S. Food and Drug Administration (FDA) has approved Hulio, a biosimilar of Humira (adalimumab), for the treatment of adults with Crohn’s disease and ulcerative colitis — both forms of inflammatory bowel disease. However, the biosimilar, which was developed by Mylan and Fujifilm Kyowa Kirin Biologics, will not be available in the U.S. until 2023, when Humira’s patent expires. Hulio is expected to be launched in July 2023, according to Mylan’s agreement with AbbVie, Humira's developer. The deal includes payment of licensing royalties to AbbVie upon Hulio's launch. The FDA's approval of Hulio also covers five additional indications: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults, and juvenile idiopathic arthritis in patients ages 4 and older. “We are very pleased with FDA’s approval of Hulio, a biosimilar to the world’s top selling drug Humira, which will help bring another treatment option to U.S. patients living with chronic inflammatory conditions,” Rajiv Malik, Mylan’s president, said in a press release. A biosimilar is a medical product with similar properties — as well as comparable safety and effectiveness — to an original biological therapy, but manufactured by a different company. Similar to generics, biosimilars are usually more affordable than the reference, or original medicine. Hulio (adalimumab-fkjp) will be available in both prefilled syringes and auto-injector pens. It is now the sixth Humira biosimilar to gain FDA approval in the U.S., following Amgen’s Amjevita in 2016, Boehringer Ingelheim’s Cyltezo in 2017,  Sandoz’s Hyrimoz in 2018, Samsung Bioepis’ Hadlima in early 2019, and Pfizer’s Abrilada in late 2019. All of these b
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