The U.S. Food and Drug Administration (FDA) has approved Hulio, a biosimilar of Humira (adalimumab), for the treatment of adults with Crohn’s disease and ulcerative colitis — both forms of inflammatory bowel disease.
However, the biosimilar, which was developed by Mylan and Fujifilm Kyowa Kirin Biologics, will not be available in the U.S. until 2023, when Humira’s patent expires.
Hulio is expected to be launched in July 2023, according to Mylan’s agreement with AbbVie, Humira’s developer. The deal includes payment of licensing royalties to AbbVie upon Hulio’s launch.
The FDA’s approval of Hulio also covers five additional indications: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults, and juvenile idiopathic arthritis in patients ages 4 and older.
“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.
A biosimilar is a medical product with similar properties — as well as comparable safety and effectiveness — to an original biological therapy, but manufactured by a different company. Similar to generics, biosimilars are usually more affordable than the reference, or original medicine.
Hulio (adalimumab-fkjp) will be available in both prefilled syringes and auto-injector pens. It is now the sixth Humira biosimilar to gain FDA approval in the U.S., following Amgen’s Amjevita in 2016, Boehringer Ingelheim’s Cyltezo in 2017, Sandoz’s Hyrimoz in 2018, Samsung Bioepis’ Hadlima in early 2019, and Pfizer’s Abrilada in late 2019.
All of these biosimilars will become available in the U.S. in 2023, upon the expiration of Humira’s patent.
“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,” Malik said.
He also noted Mylan’s “strategic partnerships, such as the one we are proud to have with Fujifilm Kyowa Kirin Biologics.”
The FDA’s decision follows a similar, recent approval of Hulio in Japan, as well as the therapy’s first approval in the European Union, where it is now available in more than 20 countries, according to Fujifilm.
Like Humira, Hulio is an antibody that blocks the activity of tumor necrosis factor, a pro-inflammatory molecule produced in excess in different types of autoimmune diseases.
Hulio’s approvals were partly based on data from the ARABESC Phase 3 clinical trial (NCT02260791), which compared Hulio with Humira in 728 adults with rheumatoid arthritis. The results showed no clinically meaningful differences between the two therapies in terms of safety, effectiveness, or immunogenicity, which is the treatment’s ability to trigger an immune response.
Fujifilm Kyowa Kirin entered into a partnership with Mylan in 2018 for the commercialization of Hulio in Europe, and expanded it globally in 2019.
“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’s president and CEO.
“In cooperation with Mylan, we continue to make all efforts to deliver this high quality and affordable biosimilar throughout the world,” he added.
Like Humira, Hulio’s prescribing information includes a warning for a higher risk for serious infections leading to hospitalization or death. It also warns of a potential increased risk for lymphoma and other types of cancer associated with its use.