Shots:

• The US FDA has accepted the sBLA for a citrate-free, high-concentration (100 mg/mL) formulation of SB5, a biosimilar referencing Humira (adalimumab). SB5 will be commercialized in the US by Organon & is expected to launch in the US on July 1, 2023
• The sBLA was based on the clinical data from a single-dose study to evaluate the PK, safety, tolerability, and immunogenicity of SB5 (100 mg/mL vs 50 mg/mL) in healthy volunteers
• In July 2019, SB5 has approved in the US under the brand name Hadlima as a low-concentration (50 mg/mL) formulation. Additionally, the low & high concentration forms of the reference product are marketed in the US

Ref: Center for Biosimilars | Image: Samsung Bioepis