FDA approves Hulio, sixth Humira biosimilar
The FDA has approved the sixth biosimilar to adalimumab, adalimumab-fkjp, for all eligible indications of the biologic product, according to a company press release.
Hulio (adalimumab-fkjp, Mylan/Fujifilm Kyowa Kirin), a biosimilar to Humira (adalimumab, AbbVie), is a TNF inhibitor intended to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
“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,” Rajiv Malik, president of Mylan, said in a press release. “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.”
Hulio is now the sixth biosimilar to Humira to gain FDA approval in the United States, following Hadlima (adalimumab-bwwd, Samsung Bioepis) and Abrilada (adalimumab-afzb, Pfizer) in 2019. However, to date, none of these biosimilars have been launched in the U.S. market as Humira is patent-protected until 2023.
The FDA based its approval on results from the ARABESC phase 3 clinical study, which found no clinically meaningful difference in safety, efficacy and immunogenicity between Hulio and the reference product, Humira, in patients with rheumatoid arthritis.
According to the press release, Hulio carries a boxed warning for increased risk for serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. The prescribing information also includes a warning for a potential increased risk for lymphoma and other malignancies.
“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 condition,” Atsushi Matsumoto, president and CEO of Fujifilm Kyowa Kirin Biologics, said in the release. “In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world.”