On Jul. 9, 2020, Mylan and Fujifilm Kyowa Kirin Biologics announced the the U.S. Food and Drug Administration (FDA) had approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie’s Humira (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis (4 years and older), psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis, in both prefilled syringe and auto-injector presentations.

In accordance with its patent license agreement with AbbVie, Mylan will be able to launch Hulio in the U.S. during July 2023.

The approval of Hulio was based on a comprehensive analytical, preclinical and clinical program. The Phase 3 clinical study, ARABESC, conducted by Fujifilm Kyowa Kirin Biologics, demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Humira, in rheumatoid arthritis patients.

Mylan and Fujifilm Kyowa Kirin Biologics entered into a partnership in 2018 for the commercialization of Hulio in Europe and Mylan has commercialized the product in several countries across the region. In 2019, Mylan and Fujifilm Kyowa Kirin Biologics expanded the partnership globally. Recently, Hulio (Brand name in Japan: Adalimumab BS “FKB”) received regulatory approval in Japan. These approvals and launches form part of Mylan’s commitment to patients by offering one of the industry’s largest and most diverse global biosimilars franchises focused on the areas of oncology, immunology, endocrinology, ophthalmology and dermatology.

Humira had brand sales of approximately $14.9 billion in the U.S. for the 12 months ending December 2019, according to AbbVie’s 2019 annual report.

Hulio carries a Boxed Warning for an increased risk of serious infections leading to hospitalization or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal infections and infections due to opportunistic pathogens. Hulio should be discontinued if a patient develops a serious infection or sepsis during treatment. Test for latent TB and if positive, begin TB treatment before initiating Hulio. Monitor all patients for active TB during treatment, even if the initial TB test is negative. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including Hulio. Post-marketing cases of hepatosplenic T-cell lymphoma have occurred in young adults with inflammatory bowel disease treated with TNF blockers including Hulio.