Samsung Bioepis strengthens data package on Humira biosimilar

Korean biosimilar company Samsung Bioepis is presenting new data on its copy of Humira (adalimumab), which is branded as Imraldi and Hadlima and also referred to as SB5, at the Annual European Congress of Rheumatology (EULAR 2022).

This includes data from a Phase I trial comparing the pharmacokinetic (PK), safety, and tolerability profile of the new SB5 formulation (40 mg/0.4 mL) with the original SB5 formulation (40 mg/0.8 mL) in healthy men.

In a randomized, single-blind, two-arm, parallel group, single-dose study in healthy subjects, the study demonstrated PK equivalence between the new SB5 formulation and the original. Both were generally well tolerated with similar safety profiles.