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)

Grandbrothers

  • 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.

Recommended For You

Comments

To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.
Is this happening to you frequently? Please report it on our feedback forum.
If you have an ad-blocker enabled you may be blocked from proceeding. Please disable your ad-blocker and refresh.