• Phase 3 study shows biosimilarity of SB16 with reference denosumab through equivalent efficacy and comparable pharmacodynamics (PD), PK, immunogenicity, and safety up to Month 12
INCHEON, Korea – October 16, 2023 – Samsung Bioepis Co., Ltd. today presented two clinical study data for SB16, a proposed biosimilar to Proliai (denosumab), at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting being held from October 13 to 16 in Vancouver, BC, Canada.
The Phase 1 study was a randomized, double-blind, three-arm, multi-center, parallel group and single-dose study to demonstrate the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced denosumab (US-DEN) in healthy male participants. The primary PK endpoints were area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration. All of the corresponding 90% Confidence Intervals (CIs) of geometric least squares means (LSMeans) ratio of primary PK parameters for comparison of SB16 and EU-DEN, SB16 and US-DEN, and EU-DEN and US-DEN were within the pre-defined equivalence margin (0.80-1.25).
The Phase 3 study was a randomized double-blind study to compare efficacy, safety, PK, pharmacodynamics (PD) and immunogenicity of SB16 with reference denosumab in postmenopausal osteoporosis (PMO) patients. The study met its primary endpoints – percent (%) change from baseline in lumbar spine bone mineral density (BMD) at Month 12 – with the difference in LSMeans % of 0.39 for per-protocol set (95% CI: −0.36 - 1.13), 0.33 for full analysis set (90% CI: −0.25 - 0.91), being fully contained within the pre-defined equivalence margin.
“We are pleased to present clinical data for SB16 for the first time at the ASBMR Annual Meeting. Through Phase 1 and 3 clinical studies, SB16 demonstrated biosimilarity to reference denosumab, meeting all the primary endpoints in both studies,” said Ilsun Hong, Vice President and Product Evaluation Team Leader at Samsung Bioepis. “As we continue to advance with our biosimilar development, our endeavors to enhance understanding of biosimilars among healthcare professionals will continue through our scientific research, publication and educational activities,” she added.
The details of the SB16 abstracts presented at ASBMR 2023 Annual Meeting are as below:
A Phase I, Randomized, Double-blind, Single-dose Study to Evaluate the Biosimilarity of SB16 (Proposed Denosumab Biosimilar) with Reference Denosumab in Healthy Male Subjects
Presentation Number: SAT-447
Presentation Type: Poster Presentation
Session: Poster Session I
Session Date/Time: Saturday, October 14, 2023, 1:30 pm – 3:00 pm
A Randomized, Double-blind, Phase III Study to Compare SB16 (Proposed Denosumab Biosimilar) to Reference Denosumab in Patients with Postmenopausal Osteoporosis
Presentation Number: SUN-432
Presentation Type: Poster Presentation
Session: Poster Session II
Session Date/Time: Sunday, October 15, 2023, from 1:30 pm – 3:00 pm
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About SB16 Phase 1 Study
In a randomized, double-blind, three-arm, multi-center, parallel group and single-dose study, 168 healthy male subjects between 28-55 years of age were randomized in a ratio of 1:1:1 to receive a single 60 mg dose of either SB16, EU-DEN, or US-DEN subcutaneously. PK, PD, safety, tolerability, and immunogenicity were evaluated for 197 days. The primary PK endpoints were AUC from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration. Equivalence was determined if 90% CIs for the ratio of geometric LSMeans of the treatment groups compared were within the equivalence margin of 0.80 to 1.25.
About SB16 Phase 3 Study
457 PMO patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at Month 0, Month 6, and Month 12. At Month 12, patients in DEN group were re-randomized in a 1:1 ratio to switch to SB16 or maintain DEN. The primary endpoint was percent (%) change from baseline in lumbar spine BMD at Month 12. Equivalence between SB16 and DEN was declared if the 95% CI (per-protocol set) and 90% CI (full-analysis set) of LSMeans difference of % change in lumbar spine BMD at Month 12 were within the pre-defined equivalence margin. Other secondary efficacy, PD (serum C-telopeptide of type I collagen [CTX] and procollagen type I N-terminal propeptide [P1NP]), PK, immunogenicity, and safety endpoints were also measured.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com
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