At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).
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.
Unlocking Biosimilar Potential in Specialty Pharmacies With Legislative Support, Formulary Changes
April 24th 2025Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Biosimilar and Biologic Use Increasing in Greek Patients With IBD
April 19th 2025A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.