BRIEF—US FDA approves another Humira biosimilar, Hulio

Mylan and Fujifilm Kyowa Kirin Biologics today announced that the US Food and Drug Administration has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie's Humira (adalimumab), for the treatment of 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.

In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the USA during July 2023.

Hulio gained approval in Europe in 2018.

The approval of Hulio was based on a comprehensive analytical, preclinical and clinical program.

The Phase III 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.

Humira had brand sales of around $14.9 billion in the USA for the 12 months ending December 2019, according to AbbVie's 2019 annual report.