Hadlima is developed, manufactured and supplied by Samsung Bioepis, and commercialized by Organon

The U.S. Food and Drug Administration (FDA) has accepted the Supplemental Biologics License Application (sBLA) for the interchangeability designation or Hadlima (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira(adalimumab).

Once a biosimilar product is designated as an interchangeable biosimilar by the FDA, it can be used to replace the reference product by someone other than the prescriber without the need to consult the prescriber.

The sBLA, which was submitted to the FDA by Samsung Bioepis in August 2023, was based on clinical data from the Phase 4 study assessing 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. Hadlima is developed, manufactured and supplied by Samsung Bioepis, and commercialized by Organon

“An interchangeability designation may play a role beyond enabling pharmacy substitution. 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. We remain committed to helping more patients access biosimilar alternatives,” says Jon Martin, Head, US Biosimilars at Organon, in a news release.

Hadlima was first approved by the FDA in July 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and prefilled autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and prefilled autoinjector of HADLIMA was approved in August 2022. Hadlima was introduced into the US commercial market on July 1, 2023 and is marketed by Organon.