Mylan, Fujifilm Kyowa Kirin Biologics Announce FDA Approval of Hulio

Mylan and Fujifilm Kyowa Kirin Biologics announced the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie's Humira® (adalimumab), 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, in both prefilled syringe and auto-injector presentations.

"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. With one of the industry's largest and most diverse global biosimilars franchises, Mylan is committed to improving patient access to this and other critically important biologic medicines as well as providing more affordable treatment options for patients worldwide," Mylan President Rajiv Malik said.

"The FDA approval of Hulio marks a significant milestone for both Fujifilm Kyowa Kirin Biologics and Mylan, increasing access to affordable treatment for U.S. patients with inflammatory conditions." said Atsushi Matsumoto, Fujifilm Kyowa Kirin Biologics President and CEO. "In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world."

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

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.

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.

Hulio carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. Hulio should be discontinued if a patient develops a serious infection or sepsis during treatment. Test for latent TB and if positive, begin TB treatment before initiating Hulio. Monitor all patients for active TB during treatment, even if the initial TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including Hulio. Post-marketing cases of hepatosplenic T-cell lymphoma have occurred in young adults with inflammatory bowel disease treated with TNF blockers including Hulio.