FDA Approves Mylan and Fujifilm’s Humira Biosimilar

Mylan and Fujifilm Kyowa Kirin Biologics received FDA approval for Hulio (adalimumab-fkjp), a biosimilar of AbbVie’s Humira (adalimumab).

The approval was based on results of a phase 3 study in which Hulio demonstrated no differences in safety, efficacy, and immunogenicity compared with Humira for treatment of rheumatoid arthritis.

Mylan will be able to launch its biosimilar in the U.S. in July 2023 under a licensing agreement with AbbVie.