Samsung Bioepis and Organon said that the U.S. Food and Drug Administration (FDA) had accepted for review their supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration formulation of SB5, a Humira (Adalimumab) biosimilar.

The FDA has decided to review Samsung Bioepis’ and Organon’s supplemental Biologics License Application (sBLA) for a high-concentration formulation of SB5, a Humira biosimilar.
The FDA has decided to review Samsung Bioepis’ and Organon’s supplemental Biologics License Application (sBLA) for a high-concentration formulation of SB5, a Humira biosimilar.

SB5 also received approval from the FDA under the brand name Hadlima as a low-concentration (50 mg/mL) formulation in July 2019.

The two companies submitted sBLA for SB5 in October 2021 by including the data of a randomized, single-blind, two-arm, parallel-group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 (100 mg/mL vs. 50 mg/mL) in healthy volunteers.

Samsung Bioepis plans to commercialize SB5 in the U.S. through Organon. If approved, the two companies expect to launch it on or after July 1, 2023, according to a licensing agreement with AbbVie.

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