Samsung Bioepis and Organon Report Interchangeability Study Results of SB5 (biosimilar, adalimumab) for Chronic Plaque Psoriasis
- The results from the interchangeability P-IV study of SB5 across 33 sites in 4 countries (Bulgaria, Czechia, Lithuania, Poland). The primary objective of the study was to evaluate the PK similarity b/w 2 treatment groups in patients who switched multiple times b/w Humira (ADL) and high-concentration SB5 vs patients receiving ADL continuously
- The study achieved all 1EPs (PK endpoints of AUCtau and Cmax at 23-25wk.) while efficacy profiles, safety profiles, and immunogenicity were also comparable b/w 2 treatment groups
- SB5 was approved in the US under the brand name Hadlima as a low-concentration (50mg/mL) formulation of the prefilled syringe and autoinjector while a high-concentration (100 mg/mL) formulation was approved in Aug 2022
Ref: Organon | Image: Organon
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