Mylan, Fujifilm Kyowa Kirin Biologics obtain FDA nod for Humira biosimilar

Patients with certain chronic inflammatory conditions, will have a new generic treatment option.  

Mylan and Fujifilm Kyowa Kirin Biologics have received the Food and Drug Administration’s clearance for Hulio (adalimumab-fkjp), a biosimilar to AbbVie's Humira (adalimumab), that comes in prefilled syringe and auto-injector presentations.

The product is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

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. 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."

"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 resident and CEO. "In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world."

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

Hulio is expected to be launched in July 2023.