The 6th Adamu monotonica biosimilar! Mylan/Concord Kirin Hulio has been approved by the U.S. FDA and will be available in 2023!

July 11, 2020 // Mylan and partner Fujifilm Kyowa Kirin have jointly announced that the U.SFood and Drug Administration (FDA) has approved Hulio, amumuab-fkjp, a superweight product from AbbVie:: adalimumab, adallumsaab) biosimilars for treatment: rheumatoid arthritis (RA), juvenile isoarthritis (JIA, age 4 years), psoriasis arthritis (PsA), aggressive spinaencephaly (AS), adult Crohn's disease (CD), ulcerative colitis (UC), plaque type psoriasis (PSO)was allowed to bring Hulio to the U.Smarket in July 2023 under a previous license agreement with AbbVie"We are very pleased that the FDA has approved Hulio, a biosimilar to Humira, the world's best-selling drug, that will help bring another high-quality, more affordable treatment option for U.Spatients with chronic inflammation," said Rajiv Malik, president ofmyland", this approval is based on a comprehensive analytical, preclinical and clinical projecta Phase III clinical study conducted by Concord Kirin, the results of ARABESC showed that there was no clinical difference between Hulio and the reference product Humira in terms of safety, efficacy, and immunogenicity in patients with rheumatoid arthritis (RA)Hulio is a biosimilar of Adamu monoto-resistance developed by Concord KirinApril 2018, Mylan partnered with Concord Kirin to acquire Hulio's exclusive commercialization rights in Europein Europe, Hulio was approved in September 2018 for all of Humira's indicationsin 2019, Mylan and Concord Kirin will expand their partnership globallyat the end of June, Hulio was approved in Japanto date, these approvals and product launches have formed part of Mylan's commitment to patients, focusing on oncology, immunology, endocrinology, and dermatology by offering one of the industry's largest and most diverse global biosimilars franchisesthe FDA's Biosimilar Database, the agency has so far approved 28 biosimilars Hulio is the second biosimilar approved by the FDA in 2020 and the sixth to date approved by the agency for aadamizumaseta biosimilars in addition to Thehulio of Mylan/Concord Kirin, the other five approved Abrida (Pfizer, November 2019), Hadlima (Samsung Bioepis/Mercadon, 20) July 19), Hyrimoz (Novartis, October 2018), Cyltezo (Bollinger Ingham, August 2017), Amjevita (Amgen, September 2016) Humira, abbrevia's flagship product, is the world's first approved anti-tumor necrosis factor TNF-alpha drug, which is also the world's best-selling anti-inflammatory drug, and has been approved in more than 90 countries around the world, including: Rheumatoid arthritis is found in, juvenile isoarthritis, psoriasis arthritis, hyperthyroidism, adult Crohn's disease, pediatric Crohn's disease, ulcerative colitis, psoriasis, septic sweat adenine and vitimetinitis Humira is a super-heavyweight product of AbbVie, which has been the world's "drug king" for several years, with global sales of $19.169 billion in 2019, down slightly from the previous year (3.9 percent) , U.S sales were $14.864 billion and international sales were $4.305 billion(mostly in Europe) in Europe, a number of Adamumono biosimilars are currently on the market, but in the U.S., AbbVie has reached settlement agreements with nine pharmaceutical companies, including Amgen, Samsung Bioepis/Mercado, Mylan, Sanders, Fresenius Kabi, Momenta, Pfizer, Coherus BioSciences, and Bollinger Ingham under the terms of the agreement, these companies' Adamu monotonica biosimilars will be available on the U.S market at different points in 2023 and will not be available early because of the listing of other authorized corporate products () Original source: Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S FDA Approve of Hulio ® (adalimumab-fkjp)