Benzinga | Jan 5, 2022 06:31AM EST

FDA Accepts Samsung Bioepis' And Organon's sBLA For Their Citrate-Free, High-Concentration HUMIRA Biosimilar Candidate

Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE:OGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing HUMIRA(r) (adalimumab).1 SB5 was previously approved by the FDA under the brand name HADLIMA(tm) as a low-concentration (50 mg/mL) formulation in July 2019. The low concentration and high concentration forms of the reference product are both marketed in the United States (U.S.) today.

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The sBLA for citrate-free, high-concentration adalimumab was submitted by Samsung Bioepis in October 2021 and was based on clinical data from 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.

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