Samba Epis announces Phase 3 results of Stelara biosimilar in Europe... "Equivalence confirmed"

Autoimmune Disease Treatment Biosimilar 'SB17'
Clinical Medical Equivalence Confirmed in Efficacy and Safety
"Will Continue Efforts to Raise Awareness of Biosimilars"

Samsung Bioepis announced on the 12th that it presented the Phase 3 clinical trial results of the Stelara biosimilar 'SB17' (generic name ustekinumab) for the first time at the annual meeting of the European Academy of Dermatology & Venereology (EADV), held in Berlin, Germany, from the 11th to the 14th (local time).

Exterior view of Samsung Bioepis building in Songdo, Incheon.
[Photo by Samsung Bioepis]

The original drug Stelara, on which SB17 is based, was developed by Janssen and is an autoimmune disease treatment for plaque psoriasis, psoriatic arthritis, Crohn's disease, and others. It works by inhibiting the activity of interleukin (IL)-12 and IL-23.

Samsung Bioepis completed the Phase 3 clinical trial of SB17 last November, involving 503 patients with moderate to severe plaque psoriasis across eight countries globally, including South Korea. The company explained that through this study, clinical equivalence in efficacy and safety between the biosimilar and the original drug was confirmed.

According to the abstract released at the conference, the 503 clinical trial participants were randomly assigned in a 1:1 ratio to receive either SB17 or the original drug. At week 28 of the trial, participants initially assigned to the original drug group were re-randomized into two groups: one switching to SB17 at a 1:1 ratio, and the other continuing with the original drug. Participants initially assigned to the SB17 group received SB17 every 12 weeks up to week 40.

Samsung Bioepis measured the primary efficacy endpoint of the SB17 Phase 3 trial as the percentage change from baseline in the Psoriasis Area and Severity Index (PASI) at week 12, and the results met the pre-defined equivalence criteria. Furthermore, efficacy and safety up to week 28 were also confirmed to be similar.

SB17 is the fourth autoimmune disease treatment developed by Samsung Bioepis, following SB4 (Enbrel biosimilar, generic name etanercept), SB2 (Remicade biosimilar, generic name infliximab), and SB5 (Humira biosimilar, generic name adalimumab). Last month, Samsung Bioepis signed a partnership agreement with Swiss pharmaceutical company Sandoz for the sales of SB17 in North America and Europe. Sandoz is a generic and biosimilar specialist company newly established by Novartis after splitting off its generic and biosimilar business units.

Kim Hye-jin, Medical Team Leader (Executive Director) at Samsung Bioepis, stated, "The research results on safety and efficacy between our product and the original drug disclosed at this conference are meaningful as an example of our continuous efforts to enhance positive perceptions of biosimilars among doctors and patients."

Meanwhile, Samsung Bioepis also disclosed real-world data (RWD) analysis results over four years post-launch on the efficacy and safety of SB5 in patients with moderate to severe psoriasis at this conference.

The original drug of SB17, Stelara, is an autoimmune disease treatment developed by Janssen, a subsidiary of Johnson & Johnson. According to IQVIA, a pharmaceutical market research firm, the global ustekinumab market size reached $17.713 billion (approximately 23.71 trillion KRW) last year, making it a blockbuster drug. Besides Samsung Bioepis, among domestic companies, Celltrion has applied for marketing authorization for the Stelara biosimilar 'CT-P43' in South Korea, the United States, Europe, Canada, and Australia. Dong-A ST also completed Phase 3 clinical trials for the Stelara biosimilar 'DMB-3115' and applied for marketing authorization to the European Medicines Agency (EMA) in July.

This content was produced with the assistance of AI translation services.