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Mylan, Fujifilm Kyowa Kirin Receive FDA Approval Of Hulio - Quick Facts

Pharmaceutical companies Mylan N.V. (MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. announced Thursday that the U.S. Food and Drug Administration (FDA) has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie's Humira (adalimumab). This will help bring another affordable treatment option to U.S. patients living with chronic inflammatory conditions.

Hulio, in both prefilled syringe and auto-injector presentations, is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis in 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the U.S. during July 2023. Humira had brand sales of approximately $14.9 billion in the U.S. for the 12 months ending December 2019, according to AbbVie's 2019 annual report.

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

Mylan and Fujifilm Kyowa Kirin Biologics entered into a partnership in 2018 for the commercialization of Hulio in Europe and Mylan has commercialized the product in several countries across the region. In 2019, Mylan and Fujifilm Kyowa Kirin Biologics expanded the partnership globally.

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