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FDA Approves Samsung Bioepis’ Unbranded Adalimumab Biosimilar

Jun 23, 2025

On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®.

Samsung Bioepis is not the first to offer an unbranded US adalimumab biosimilar, with the FDA approving Celltrion’s sBLA for unbranded Yuflyma® (adalimumab-aaty) in November 2023.

In May 2025, the FDA expanded interchangeability for Samsung Bioepis’ Hadlima® in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe.  In the same month, the FDA also granted Celltrion’s Yuflyma® expanded interchangeability to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations.  According to the companies, both biosimilars are now fully interchangeable with AbbVie’s Humira®.

The first high-concentration biosimilar to AbbVie’s Humira® to receive an interchangeability designation was Alvotech and Teva’s Simlandi®, which was approved in February 2024.