The U.S. Food and Drug Administration has approved Mylan and Fujifilm Kyowa Kirin Biologics’ adalimumab-fkjp as a biosimilar to AbbVie’s adalimumab for a variety of inflammatory disease including plaque psoriasis and psoriatic arthritis.
Adalimumab-fkjp (Hulio, Mylan and Fujifilm Kyowa Kirin Biologics) is now approved by the U.S. Food and Drug Administration (FDA) for the treatment of psoriatic arthritis and plaque psoriasis.
The biosimilar is also approved to treat other inflammatory diseases including juvenile idiopathic arthritic, rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis as well as adult Crohn's disease and is approved for both auto-injector and pre-filled syringes, according to a company press release.
The drug, a tumor necrosis factor (TNF) blocker, is a biosimilar to adalimumab (Humira, AbbVie).
"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,” says Rajiv Malik, president of Mylan. “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 approval decision is supported by positive phase 3 clinical study results (ARABESC) which exhibited no clinically meaningful differences in immunogenicity, efficacy and safety in comparison to adalimumab in patients with rheumatoid arthritis.
“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." Says Atsushi Matsumoto, president and CEO of Fujifilm Kyowa Kirin Biologics. "In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world."
In a patent license agreement between AbbVie and Mylan, the latter will introduce adalimumab-fkjp to the U.S. in July 2023. Most recently, the drug was approved in Japan
1. Mylan and Fujifilm Kyowa Kirin Biologics Announce U.S. FDA Approval of Hulio® (adalimumab-fkjp). (2020, July 9). Retrieved July 13, 2020, from http://newsroom.mylan.com/2020-07-09-Mylan-and-Fujifilm-Kyowa-Kirin-Biologics-Announce-U-S-FDA-Approval-of-Hulio-R-adalimumab-fkjp