Hulio, Humira Biosimilar, Approved But Not Available Until 2023

The U.S. Food and Drug Administration (FDA) has approved Hulio, a biosimilar of Humira (adalimumab), to treat chronic inflammatory disorders such as ankylosing spondylitis.

However, Hulio (adalimumab-fkjp) — developed by Mylan and Fujifilm Kyowa Kirin Biologics — will not be available in the U.S. until July 31, 2023, due to a patent agreement with AbbVie, the company that markets Humira.

The approval also covers the treatment of adults with rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, plaque psoriasis, as well as Crohn’s disease and ulcerative colitis, two forms of inflammatory bowel disease.

Hulio will be available as both pre-filled syringes and auto-injectors. Mylan will pay royalties to AbbVie once the biosimilar is launched.

“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, Mylan’s president, said in a press release.

“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,” Malik added.

“In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world,” Atsushi Matsumoto, president and CEO at Fujifilm Kyowa Kirin Biologics, added.

Biosimilars mimic the effects of a reference biological therapy — in Hulio’s case, Humira. Although they are differently produced and regulated, both biosimilars and generics are alternatives with similar effectiveness, safety, dosing and route of administration to an existing treatment. Biosimilars and generics are typically more affordable than the reference therapy.

The FDA’s decision was based on positive results from the ARABESC Phase 3 clinical trial (NCT02260791)in patients with rheumatoid arthritis. Results showed no clinically meaningful differences compared to Humira in terms of safety, efficacy and immunogenicity — a treatment’s tendency to induce an immune response.

The European Commission approved Hulio to treat ankylosing spondylitis and other chronic inflammatory disorders in 2018, also based on this study’s results.

AbbVie has similar agreements for two other FDA-approved biosimilars of Humira: Amgen‘s Amjevita (adalimumab-atto) and Samsung Bioepis‘ Hadlima (adalimumab-bwwd). While Amjevita is set to enter the U.S. market on Jan. 31, 2023, Hadlima will be available five months later.

Both these biosimilars also became available across Europe in 2018.