EMA accepts Sandoz application for Humira biosimilar

June 21, 2022

The European Medicines Agency has accepted Sandoz’s application for regulatory review of Hyrimoz, the company’s high concentration biosimilar of AbbVie's Humira.

If approved, Hyrimoz would be used for the treatment of all indications covered by Humira, which include autoimmune and inflammatory diseases, such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and uveitis.

Since its launch in the United States in 2003, Humira has remained the top-selling drug of all time. After extensive litigation, AbbVie has entered into settlements with several manufacturers to allow for a 2023 launch of biosimilars. Sandoz’s biosimilar had been initially approved as a 50-mg/mL formulation, but the latest application submitted is for its higher-concentration 100-mg/mL dose.  

The new formulation will also be free from excipient citrates and use the same auto-injector as its predecessor.

Florian Bieber, Global Head of Biopharmaceuticals Development at Sandoz said that “By committing to bring biosimilar formulations such as Hyrimoz citrate-free HCF to patients, we are serving a critical need in expanding access to important medicines and fueling pharmaceutical innovation.”