Samsung Bioepis and Organon (NYSE:OGN) announce that the 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 AbbVie's HUMIRA (adalimumab).
SB5 was previously approved by the FDA under the brand name HADLIMA as a low-concentration (50 mg/mL) formulation in July 2019.
The sBLA for citrate-free, high-concentration adalimumab was based on clinical data from a randomized, two-arm, 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 is expected to launch in U.S. on or after July 1, 2023, in accordance with a licensing agreement with AbbVie.