Samsung Bioepis’ Stelara Biosimilar Proves Successful in Phase 1 Study

SB17, an ustekinumab biosimilar developed by Samsung Bioepis, had comparable safety, pharmacokinetic (PK), tolerability, and immunogenicity profiles to the reference product (Stelara) in phase 1 clinical trial results.

Samsung Bioepis shared the positive results at the American Academy of Dermatology annual meeting held in New Orleans, Louisiana from March 17 to March 21, 2023.

The trial was a randomized, double-blind, single-dose comparative PK study that included 201 healthy subjects. The participants were randomized to receive a single 45 mg dose of the biosimilar, the EU-sourced reference product, or the US-sourced reference product subcutaneously.

The primary endpoint of the study was area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax).The secondary endpoint were to investigate and compare the safety, tolerability, and immunogenicity between three treatment groups.

For all comparisons of primary endpoints the 90% CI of the geometric least squares means ratio were within the pre-defined equivalence margin of 0.80-1.25. Safety profiles and immunogenicity were also comparable among the groups.

Ustekinumab products are monoclonal antibodies that inhibit tumor necrosis factor. They are used to treat several immunology conditions, including plaque psoriasis, ulcerative colitis, Crohn disease, and psoriatic arthritis.

In July 2019, Samsung Bioepis announced that it began a phase 3 trial for SB17. The trial aimed to compare the safety and efficacy of the biosimilar with that of the reference product in 464 patients with moderate-to-severe plaque psoriasis. Patients were randomized to receive the biosimiar or reference product. Patients enrolled in the reference product group were re-randomized at week 28 to either continue treatment with Stelara or to switch to the biosimilar. A final assessment was scheduled for week 52. The study completed late last year.

Other Ustekinumab Biosimilars in the Pipeline

The European Union is currently reviewing an application for an ustekinumab biosimilar developed through a partnership between Alvotech and STADA Arzneimittel. In January 2023, the FDA accepted a biologics license application for the same product. Fresenius Kabi has also partnered with Formycon to develop an ustekinumab biosimilar.

In January 2023, Dong-A ST announced that a phase 3 therapeutic equivalence study demonstrated that its ustekinumab biosimilar (DMB-3115) has similar safety and efficacy profiles to Stelara. The phase 3 study was conducted in 2021 in the United States and 9 other countries, such as Poland, Estonia, and Latvia. The study included 605 participants with moderate to severe chronic plaque psoriasis and evaluated the safety, efficacy, and immunogenicity of DMB-3115 over 52 weeks.

In addition, Rani Therapeutics, a clinical stage biotherapeutics company based in California, announced that it has started the preclinical development process for RT-111, a RaniPill GO capsule using an ustekinumab biosimilar. The RaniPill Go device was created to address the unmet need for oral biologic medications, and Rani Therapeutics claims that the oral delivery platform can administer any drug, including large molecules, such as peptides, proteins, and antibodies.