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# FDA Will Review sBLA for Humira Biosimilar
- URL: https://www.fdaweb.com/fda-will-review-sbla-for-humira-biosimilar/
- Published: 2022-01-05T12:00:00.000Z
- Updated: 2026-09-14T17:27:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150872

FDA has accepted for review a Samsung Bioepis/Organon sBLA for their citrate-free, high-concentration formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing AbbVie’s Humira (adalimumab). A Samsung [statement](https://www.marketwatch.com/press-release/fda-accepts-samsung-bioepis-and-organons-sbla-for-their-citrate-free-high-concentration-humira-adalimumabbiosimilar-candidate-2022-01-05?tesla=y&ref=fdaweb.com) says FDA previously approved SB5 as

Hadlima, a low-concentration formulation of Humira, in 7/2019.

Samsung Bioepis submitted the sBLA for citrate-free high-concentration adalimumab 10/2021 based on clinical data from a study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of the two formulations of SB5 in healthy volunteers.

The company says SB5 will be commercialized in the U.S. by Organon and is expected to launch on or after 7/1/23 under a licensing agreement with AbbVie.