In addition to JIA, the new Hulio approval covers the treatment of adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. Two forms of inflammatory bowel disease — Crohn’s disease and ulcerative colitis — also are covered in the FDA approval.
“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. “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.”
Biosimilars such as Hulio are designed to replicate the effect of a reference biological therapy — in this case, Humira. Despite differences in how they are produced and regulated, biosimilars are like generics, in that they are meant to provide alternatives with similar effectiveness, safety, and dosing to an existing product. Usually, biosimilars are more affordable than the reference medicine.
Hulio was approved based on data from the Phase 3 clinical trial ARABESC (NCT02260791), which enrolled participants with rheumatoid arthritis. The results of the randomized, double-blind, Phase 3 trial showed no clinically meaningful differences between Hulio and Humira in terms of safety, efficacy, or immunogenicity. Immunogenicity is a medicine’s tendency to induce an immune response. The biosimilar had already been approved by the European Commission in 2018.
“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, president and CEO of Fujifilm Kyowa Kirin.
“In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world,” he added.
AbbVie has similar agreements in place for two other FDA-approved biosimilars of Humira: Amgen‘s Amjevita (adalimumab-atto) and Samsung Bioepis‘ Hadlima (adalimumab-bwwd). Amjevita is set to enter the U.S. market on January 31, 2023, while Hadlima will launch on June 30, 2023.
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