FDA Approves Biosimilar to Humira

The FDA has approved adalimumab-fkjp (Hulio, Mylan), a biosimilar to adalimumab (Humira, AbbVie), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis in patients aged 4 years and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis. The new biosimilar is available in both prefilled syringe and auto-injector presentations.

As part of a patent license agreement with AbbVie, Mylan plans to launch adalimumab-fkjp in the United States in July 2023.

"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 US patients living with chronic inflammatory conditions,” said Mylan President Rajiv Malik, 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, 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 was based on the phase 3 clinical study, ARABESC, a comprehensive analytical, preclinical, and clinical program, according to the press release. The results showed no clinically meaningful differences in terms of safety, efficacy, and immunogenicity compared with reference adalimumab in treating patients with RA.

Adalimumab-fkjp carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to opportunistic pathogens. Adalimumab-fkjp should be discontinued if a patient develops a serious infection or sepsis during treatment.

Lymphoma and other malignancies, some of which were fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab-fkjp. Further, post-marketing cases of hepatosplenic T-cell lymphoma were reported in young adults with inflammatory bowel disease treated with TNF blockers, including adalimumab-fkjp.

Adalimumab had brand sales totaling approximately $14.9 billion in the United States for the 12 months ending December 2019, according to AbbVie's 2019 annual report.