Pharmaceutical company Mylan NV (NASDAQ:MYL) and Fujifilm Kyowa Kirin Biologics Co Ltd on Thursday jointly announced US Food and Drug Administration (FDA) approval for Hulio (adalimumab-fkjp) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.
Hulio, a biosimilar to AbbVie's Humira (adalimumab), was approved in both prefilled syringe and auto-injector presentations.
Humira had brand sales of approximately USD14.9bn in the US for the 12 months ending December 2019.
Under a patent licence agreement with AbbVie, Mylan will be able to launch Hulio in the US in July 2023.
The FDA approval of Hulio was based on a comprehensive analytical, preclinical and clinical programme. 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.
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