Study Finds Similarities Between SB16 and Denosumab for Osteoporosis Treatment Up to 18 Months

The new findings were presented as an oral presentation at the 2024 European Calcified Tissue Society Congress, held from May 25, 2024, to May 28, 2024.

Follow-up data on SB16 (Samsung Bioepis Co Ltd), a proposed denosumab (Prolia; Amgen) biosimilar, showed the biosimilar and the reference product were comparable up to 18 months, according to a news release from the company.¹Previously, data from the phase 3 trial (up to 12 months) were presented at the American Society for Bone and Mineral Research 2023 Annual Meeting.¹

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SB16 is a human monoclonal antibody receptor activator of nuclear factor κΒ ligand. In the phase 3 study (NCT04664959), investigators compared the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the proposed biosimilar with the reference product for postmenopausal women with osteoporosis. Individuals received treatment that was randomized 1:1 to 60 mg of either SB16 or the reference product. The drugs were administered subcutaneously at month 0, month 6, and month 12, according to an abstract from the American College of Rheumatology. For the follow-up during the switching period, individuals received re-randomized treatment, either continuing treatment or switching treatment at month 12 and up to month 18.^1,2

After randomization, 225 individuals were assigned to each treatment. The mean percent change from baseline in lumbar spine bone mineral density (BMD) at 12 months was 5.6% and 5.3% for SB16 and the reference product, respectively. For hip BMD at 12 months, the mean change was 3.5% and 3.2%, respectively, and femoral neck BMD was 2.8% and 2.3%, respectively.²

Additionally, investigators reported that adverse events were comparable between both the reference product and SB16 up to 12 months.²

About The Trial

Trial Name: A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia in Postmenopausal Women With Osteoporosis

ClinicalTrials.gov ID: NCT04664959

Sponsor: Samsung Bioepis Co Ltd

Completion Date: December 2022

For the follow up data on the trial, investigators found that switching to SB16 from the reference product were comparable up to 18 months, with the lumber spin BMD being comparable at 6.77% for both products. Furthermore, the difference in lumbar spine BMD change for the full analysis was 0.03 for continuing with either the biosimilar or the reference product and –0.52 when continuing the reference product or switching to the biosimilar. Investigators also reported that the mean change from baseline for both hip BMD and femoral neck BMD were comparable at 18 months.¹

In March 2024, the FDA approved 2 biosimilars (Wyost, Jubbonti; Sandoz) for denosumab (Prolia and Xgeva; Amgen) as the first and only biosimilars that are indicated to treat all indications of the reference products. The products are in the same dosages, route of administration, regimen, and presentation as the reference medication, and both are also approved with an interchangeability designation for the reference products for all indications.³

References

1. Samsung Bioepis Announces Oral Presentation on Switching Period Results for SB16, a Proposed Biosimilar to Prolia (Denosumab) at the European Calcified Tissue Society (ECTS) Congress 2024. News release. Samsung Bioepis. May 27, 2024. Accessed June 4, 2024. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=394&currentPage=1

2. Eastell R, Langdahl B, Chung Y, et al. A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis [abstract]. Presented at: American College of Rheumatology Convergence 2023. November 10 to 15, 2024. San Diego, California.

3. Gallagher A. FDA Approves Two Denosumab Biosimilars for All Indications of Reference Products. Pharmacy Times. March 5, 2024. Accessed June 4, 2024. https://www.pharmacytimes.com/view/fda-approves-2-denosumab-biosimilars-for-all-indications-of-reference-products