Samsung Bioepis announced on March 10 the clinical results of SB5, a biosimilar to the blockbuster drug Humira, at the American Academy of Dermatology (AAD) Annual Meeting held in San Diego, California, in the U.S. on Feb. 8 (local time). This study aimed to verify whether SB5 can be interchangeably used with the original drug, Humira. The results showed that SB5 is biologically equivalent to Humira and also meets the interchangeability criteria. The study targeted patients with moderate to severe plaque psoriasis, administering the original drug before switching some patients to SB5. These patients were then evaluated for the drug's efficacy and safety.
SB5 is currently sold in the U.S. under the brand name Hadlima. Samsung Bioepis received approval for the low-concentration (50mg/mL) formulation of SB5 in 2019 and for the high-concentration (100mg/mL) formulation in 2022, launching the product in July of last year. The product is now being sold by its partner company, Organon.
Samsung Bioepis also announced the Phase 3 clinical results of SB17, a biosimilar candidate to Stelara. The study administered the original drug and SB17 to different groups of patients over 52 weeks, with some patients who received the original drug being switched to SB17. The evaluation of efficacy, safety, and immunogenicity among these patients showed that the majority of them had similar outcomes, confirming the biosimilarity to the original drug.
Last month, Samsung Bioepis received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of SB17. If the process proceeds without any issues, the company plans to launch SB17 in the European market under the brand name Pyzchiva.