New RA Biosimilar Approved for U.S. Market

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The U.S. Food and Drug Administration has approved the sixth biosimilar to Humira (adalimumab), AbbVie’s blockbuster treatment for rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and juvenile idiopathic arthritis.

Adalimumab-FKJP (Hulio), which will be manufactured by Fujifilm Kyowa Kirin Biologics, a Japanese company, and marketed here in the U.S. by Mylan N.V. in Pittsburgh, Penn., was approved for the same indications as its originator, adalimumab, except for hidradenitis suppurativa and non-infectious uveitis,

The Center for Biosimilars has reported that AbbVie has contracted with all six adalimumab biosimilar developers.

Adalimumab-FKJP is an injectable TNF that will be made available in 20 mg; 0.4 mL strengths.

The approval of adalimumab-FKJP was based on the results of a phase three rheumatoid arthritis study, ARABESC, which showed no clinically meaningful differences between the biosimilar and the originator product in terms of safety, efficacy and immunogenicity.

The new product will be sold with 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.

It is expected to be made available here in the U.S. by July 2023, according to a statement issued by Mylan.

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. Hulio recently received regulatory approval in Japan.