Organon sBLA for Humira Biosimilar Candidate Accepted for FDA Review

By Chris Wack

Organon & Co. and Samsung Bioepis Co. said the U.S. Food and Drug Administration has accepted for review the supplemental biologics license application, or sBLA, for a citrate-free, high-concentration formulation of SB5 adalimumab-bwwd, a biosimilar candidate referencing adalimumab, or Humira.

SB5 was previously approved by the FDA under the brand name Hadlima as a low-concentration--50 mg/mL--formulation in July 2019. The low concentration and high concentration forms of the reference product are both currently being marketed in the U.S.

The sBLA for citrate-free, high-concentration adalimumab was submitted by Samsung Bioepis in October, and was based on clinical data from a two-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability and immunogenicity of two formulations of SB5 in healthy volunteers, the companies said.

SB5 will be commercialized in the U.S. by Organon, the companies said. It is expected to launch in the U.S. on or after July 1, 2023, in accordance with a licensing agreement with AbbVie Inc.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 05, 2022 07:23 ET (12:23 GMT)

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