FDA approves Hadlima high concentration form as biosimilar for Humira
Samsung Bioepis and Organon announced the FDA has approved the citrate-free, high-concentration (100 mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab)
Hadlima will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. Hadlima was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018.
The approval of citrate-free, high-concentration Hadlima was based on clinical data from a randomized, single-blind, two-arm, parallel group, single-dose study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of Hadlima (100 mg/mL vs 50 mg/mL) in healthy volunteers. Hadlima is expected to be launched on or after July 1, 2023 by Organon.
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