On 27 May 2025, Samsung Bioepis announced that it has secured expanded interchangeability designation in the US for its Hadlima™ (adalimumab-aaty), biosimilar to AbbVie’s Humira®, in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe. This follows interchangeability designation for Hadlima™ in low-concentration prefilled syringe and single-dose vial presentations granted in June 2024. According to Samsung Bioepis, with this latest designation, Hadlima™ is now fully interchangeable with Humira®.
A few days earlier, on 23 May 2025, Celltrion announced that the US FDA has granted an expanded interchangeable designation for its high concentration adalimumab biosimilar, Yuflyma® (adalimumab-aaty), to include prefilled syringe (40mg) and autoinjector (40mg and 80mg) presentations. This follows interchangeability designation granted to its high-concentration 20mg and 80mg pre-filled syringe presentations in April 2025. According to Celltrion, Yuflyma® is now fully interchangeable with Humira® across all of Yuflyma®’s marketed dosage forms and strengths.
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.