US FDA approves Mylan and Fujifilm Kyowa Kirin Biologics' Hulio
10 July 2020 -

Mylan NV (NASDAQ: MYL) a United States-based generic and specialty pharmaceuticals company, and Fujifilm Kyowa Kirin Biologics Co Ltd, a company established by FUJIFILM Corporation and Kyowa Kirin Co Ltd, has received approval from the United States Food and Drug Administration (FDA) for its Hulio (adalimumab-fkjp), a biosimilar to AbbVie's Humira (adalimumab), intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (four years and older), ankylosing spondylitis, adult Crohn's disease, psoriatic arthritis, ulcerative colitis and plaque psoriasis, offered in both prefilled syringe and auto-injector presentations, it was reported on Thursday.

The product's approval was based on a comprehensive analytical, preclinical and clinical program. Fujifilm Kyowa Kirin Biologics conducted the Phase three clinical study, ARABESC that indicated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Humira, in rheumatoid arthritis patients.

Both firms collaborated in 2018 for the commercialisation of Hulio in Europe, and Mylan has commercialised the product in several countries across the region.