Mylan and Fujifilm Kyowa Kirin Biologics have been working under the partnership since 2018 for the commercialisation of Hulio
Mylan, Fujifilm Kyowa Kirin Biologics partner for Hulio. (Credit: Arek Socha from Pixabay.)
Mylan and Fujifilm Kyowa Kirin Biologics have secured the US Food and Drug Administration (FDA) approval for Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab).
Hulio was approved to treat rheumatoid arthritis, juvenile idiopathic arthritis in patients aged 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.
Fujifilm Kyowa Kirin Biologics president and CEO Atsushi Matsumoto said: “The FDA approval of Hulio marks a significant milestone for both Fujifilm Kyowa Kirin Biologics and Mylan, increasing access to affordable treatment for US patients with inflammatory conditions.
“In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world.”
The FDA approval of Hulio is based on Phase 3 ARABESC clinical study
Mylan and Fujifilm Kyowa Kirin Biologics have been working under the partnership since 2018, for the commercialisation of Hulio in Europe, where Mylan has commercialised the product in several countries across the region.
In 2019, the partnership has been expanded for global commercialisation, and recently, Hulio has been granted regulatory approval in Japan under the brand name Adalimumab.
Mylan has signed a patent license agreement with AbbVie in July 2018, for its biosimilar adalimumab product and is planning to commercialise Hulio in the US, in July 2023.
The FDA approval of Hulio was supported by an analytical, preclinical and clinical program, which includes the Phase 3 ARABESC clinical study, conducted by Fujifilm Kyowa Kirin Biologics.
The trial showed no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Humira, in rheumatoid arthritis patients.
Mylan president Rajiv Malik said: “We are very pleased with FDA’s approval of Hulio, a biosimilar to the world’s top selling drug Humira, which will help bring another treatment option to U.S. patients living with chronic inflammatory conditions.
“This approval represents yet another date-certain launch opportunity and demonstration of our commitment to expand patients’ access to medicine thanks to the power of our global platform, including our global reach and scale, our continued demonstration of scientific excellence, and the benefits of strategic partnerships, such as the one we are proud to have with Fujifilm Kyowa Kirin Biologics.