Mylan, Fujifilm Kyowa Kirin Get FDA OK for Humira Biosimilar Hulio
6:51 am ET July 9, 2020 (Dow Jones)
Mylan N.V. and Fujifilm Kyowa Kirin Biologics Co. on Thursday said the U.S. Food and Drug Administration approved Hulio, their biosimilar to AbbVie Inc.'s blockbuster drug Humira.
The companies said the approval covers the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations.
Biosimilars are near-copies of biologic drugs, such as Humira, that are made from living cells and are analogous to generic copies of traditional medicines. Humira, used to treat diseases from rheumatoid arthritis to gut disorders, is the world's biggest-selling drug.
Mylan and Fujifilm Kyowa Kirin, a venture of Japan's Fujifilm Holdings Corp. and Kyowa Kirin Co., formed a partnership in 2018 for the commercialization of Hulio.
Mylan said it will be able to launch Hulio in the U.S. during July 2023 in accordance with its patent license agreement with AbbVie.
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