New Clinical Trials for Ustekinumab & Denosumab Biosimilars Begin Recruitment

Ustekinumab Biosimilar
On March 1, Bioepsis Samsung announced it will begin phase 1 clinical trials for SB17, which is biosimilar to ustekinumab (Stelara), a humanized monoclonal antibody against interleukins 12 and 23.¹ The randomized, double-blind, clinical trial will be a three-arm, parallel study comparing the pharmacokinetics, safety, tolerability and immunogenicity of a 45 mg dose of subcutaneous ustekinumab with SB17 in healthy male volunteers (NCT04772274).²

In 2009, the U.S. Food & Drug Administration (FDA) approved ustekinumab to treat adult patients with moderate to severe plaque psoriasis.³ In 2013, the biologic agent received FDA approval for the treatment of psoriatic arthritis as monotherapy or in combination with methotrexate.⁴ Ustekinumab is also approved for the treatment of inflammatory bowel disease.

Recruiting for SB16 Trials
Two phase 3 clinical trials of SB16, which is biosimilar to denosumab (Prolia), have begun recruiting patients. The first is a randomized, double-blind, multi-center study evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of SB16 compared with denosumab in postmenopausal women with osteoporosis (NCT04664959). Patients will receive 60 mg of subcutaneous SB16 or denosumab every six months for up to 12 months.⁵

The second phase 3 trial is recruiting healthy men to study the pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of SB16 given as a single 60 mg dose (NCT04621318).

All studies are ongoing.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Samsung Bioepis Co. Ltd. News release: Samsung Bioepis initiates phase 1 clinical trial for SB17, proposed biosimilar to Stelara (ustekinumab). 2021 Mar 1.
2. Samsung Bioepis Co. Ltd. A study to compare SB17 (proposed ustekinumab biosimilar) to E.U. sourced Stelara and U.S. sourced Stelara in healthy male subjects. ClinicalTrials.gov. 2021 Feb 26.
3. U.S. Food & Drug Administration. Stelara (ustekinumab) FDA approval letter. 2020 Dec 30.
4. U.S. Food & Drug Administration. Stelera (ustekinumab) approval letter for psoriatic arthritis. 2013 Sep 20.
5. Samsung Bioepis Co. Ltd. A study to compare SB16 (proposed denosumab biosimilar) to Prolia in postmenopausal women with osteoporosis. ClinicalTrials.gov. 2020 Dec 11.
6. Samsung Bioepis Co. Ltd. Pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity study of SB16 in healthy male subjects. ClinicalTrials.gov. 2020 Nov 9.