Organon, Samsung Bioepis Humira biosimilar Hadlima high concentration dosage gets FDA nod

Aug. 17, 2022 8:08 AM ETOrganon & Co. (OGN)ABBVBy: Ravikash, SA News Editor

Headquarters of US Food and Drug Administration (FDA)


  • The U.S. Food and Drug Administration (FDA) approved a citrate-free, high-concentration (100 mg/mL) formulation of Samsung Bioepis and Organon's (NYSE:OGN) Hadlima, a biosimilar to AbbVie's (ABBV) blockbuster arthritis/psoriasis therapy Humira (adalimumab).
  • The companies said Hadlima (adalimumab-bwwd) will be available in pre-filled syringe and autoinjector options.
  • Hadlima was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019, the companies noted in an Aug. 17 press release.
  • Organon expects to launch Hadlima in the U.S. on or after July 1, in 2023.
  • Novartis' too has a Humira biosimilar Hyrimoz, whose high concentration formulation of 100 mg/mL is under review by the FDA.

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