FDA nod for citrate-free Humira biosimilar Hadlima
The US Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima (adalimumab-bwwd), a biosimilar referencing AbbVie’s (NYSE: ABBV) mega-blockbuster Humira (adalimumab). Hadlima was developed by South Korea-based Samsung Bioepis and will be commercialized by Organon (NYSE: OGN).
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 (50mg/mL) formulation in July 2019 and outside the USA that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018.
No launch until mid-2023
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