Organon sBLA for Humira Biosimilar Candidate Accepted for FDA Review
January 05 2022 - 7:38AM
Dow Jones News
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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