Samsung Bioepis and Organon Report Interchangeability Study Results of SB5 (biosimilar, adalimumab) for Chronic Plaque Psoriasis
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- 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
Related News:- Samsung Bioepis Presents Three-year Follow-up Results of SB5 (biosimilar, adalimumab) for Psoriasis at EADV 2022
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
