Mylan, Fujifilm Kyowa Humira Biosimilar OK’d

FDA has approved a Mylan and Fujifilm Kyowa Kirin Biologics Co. BLA for Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab), for treating rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations. According to its patent license agreement with AbbVie, Mylan will not launch Hulio in the U.S. until 7/2023.

Approval was based on a comprehensive analytical, preclinical and clinical program, the companies say. “The Phase 3 clinical study, ARABESC, conducted by Fujifilm Kyowa Kirin Biologics, demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Humira, in rheumatoid arthritis patients,” they say.