Samsung Bioepis Initiates Phase 3 Clinical Trial of 'SB17', a Biosimilar to 'Stelara'

Samsung Bioepis New Headquarters Exterior (Photo by Samsung Bioepis)

[Asia Economy Reporter Chunhee Lee] Samsung Bioepis's 'Stelara' biosimilar 'SB17' (generic name ustekinumab) has entered Phase 3 clinical trials.

Samsung Bioepis announced on the 20th, based on information posted on the global clinical trial information website 'ClinicalTrials' on the 19th, that from this month, Phase 3 clinical trials comparing the efficacy, safety, and immunogenicity of SB17 against the original drug are being conducted in eight countries including Poland, the Czech Republic, and Korea, targeting 464 patients with moderate to severe plaque psoriasis.

Stelara is an autoimmune disease treatment developed by Janssen, a subsidiary of Johnson & Johnson, for conditions such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is a blockbuster drug with annual global sales reaching $7.77 billion (approximately 8.8785 trillion KRW) last year.

Since February, Samsung Bioepis has been conducting Phase 1 clinical trials of SB17 on 201 healthy adults in France. In addition, by conducting Phase 3 clinical trials on actual patients, the development speed can be further accelerated.

A company official stated, “Along with existing products actively sold in Europe and other regions, we will accelerate the development of SB17 to further expand treatment accessibility for many autoimmune disease patients worldwide.”

SB17 is Samsung Bioepis's 10th biosimilar pipeline. Currently, three autoimmune disease treatments (▲SB2 (Remicade biosimilar) ▲SB4 (Enbrel biosimilar) ▲SB5 (Humira biosimilar)) and two anticancer drugs (▲SB3 (Herceptin biosimilar) ▲SB8 (Avastin biosimilar)) are already being sold in global markets including Europe. Additionally, the ophthalmic disease treatment SB11 (Lucentis biosimilar) received a positive recommendation for approval from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in June.

Furthermore, with SB17 entering Phase 3 clinical trials, all four follow-up biosimilars currently under development by Samsung Bioepis (▲SB12 (Soliris biosimilar) ▲SB15 (Eylea biosimilar) ▲SB16 (Prolia biosimilar) ▲SB17) have now entered Phase 3 clinical trials.

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