Hulio, a biosimilar to AbbVie's Humira, secured FDA approval on July 6, 2020.Developed by Mylan, Inc. (MYL), Hulio is indicated for the treatment of chronic inflammatory diseases such as rheumatoid arthritis, juvenile idiopathic arthritis for children of 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.Hulio, the sixth biosimilar to Humira, approved by the FDA, comes as a pre-filled syringe or injection pen.Amgen's Amgevita, Boehringer Ingelheim's Cyltezo, Samsung Bioepis' Hadlima, Novartis' Hyrimoz, and Pfizer's Abrilada are the other biosimilars referencing AbbVie's blockbuster drug Humira, to have been approved by the FDA. However, none of these drugs are launched in the U.S. market. As per the patent license agreement with AbbVie, Mylan will be able to launch Hulio in the U.S. during July 2023.Humira had sales of about $14.9 billion in the U.S. for the year ending December 2019.Hulio was launched in Europe in 2018 and recently the drug got regulatory approval in Japan.Hulio carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, such as tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to opportunistic pathogens.