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# Samsung Seeks Interchangeable Humira Biosimilar
- URL: https://www.fdaweb.com/samsung-seeks-interchangeable-humira-biosimilar/
- Published: 2023-11-10T12:00:00.000Z
- Updated: 2026-09-14T14:15:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155773

FDA has accepted for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Abbvie’s Humira. The submission was based on data from a Phase 4 clinical study ([NCT05510063](https://clinicaltrials.gov/study/NCT05510063?ref=fdaweb.com)) that assessed the pharmacokinetic similarity between two treatment groups: patients with moderate to severe plaque psoriasis who switched multiple times between high-concentration formulations of Humira and Hadlima versus patients receiving Humira continuously, according to the company.

“An interchangeability designation may play a role beyond enabling pharmacy substitution,” Samsung Bioepis says. “We believe that interchangeability could help increase physician confidence with prescribing biosimilars, especially in the high-concentration formulation which is used by the majority of Humira patients.”

Hadlima was first approved by FDA 7/2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. A high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector was approved 8/2022\. The biosimilar is marketed by Organon, Samsung says.