Sandoz Obtains FDA Approval for Adalimumab Biosimilar

The FDA announced today that it has approved Sandoz’s biosimilar Hyrimoz (adalimumab-adaz). The FDA had previously approved adalimumab biosimilars from Amgen and Boehringer Ingelheim.

Sandoz’s global settlement with AbbVie regarding Hyrimoz provides Sandoz with a U.S. entry date of September 30, 2023, whereas Amgen is permitted an earlier U.S. launch, on January 31, 2023.  AbbVie’s litigation regarding Boehringer Ingelheim’s adalimumab biosimilar is ongoing.

Samsung Bioepis, Mylan, and Fresenius Kabi have not reported obtaining FDA approval but have entered global settlements with AbbVie permitting June 30, 2023, July 31, 2023, and September 30, 2023 launch dates, respectively.