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
May 27 2024 - 4:00AM
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
Samsung Bioepis Co., Ltd. today presented follow-up results from
Phase 3 study on SB16, a proposed biosimilar to Prolia1 (denosumab)
as oral presentation at the 2024 European Calcified Tissue Society
(ECTS) Congress being held from May 25th to 28th in Marseille,
France. The results up to Month 12 from Phase 3 study were
previously presented at the American Society for Bone and Mineral
Research (ASBMR) 2023 Annual Meeting, and the new data presented
today are the results of the switching period, showing SB16 and
reference denosumab were comparable up to Month 18.
In this Phase 3, randomized, double-blind study,
postmenopausal osteoporosis patients were randomized in a 1:1 ratio
to receive either 60 mg of SB16 or reference denosumab (DEN)
subcutaneously at Month 0 and Month 6. At Month 12, patients were
re-randomized into switching period to continue their treatment
(SB16+SB16, or DEN+DEN) or switch from DEN to SB16 (DEN+SB16).
Efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, and
immunogenicity were assessed up to Month 18.
The follow-up on Phase 3 study demonstrated that
switching to SB16 from reference denosumab were comparable up to
Month 18 in terms of efficacy, PK, PD, safety and
immunogenicity.
The mean percent (%) change from baseline in
lumbar spine bone mineral density (BMD) at Month 18 was comparable
between treatment groups. The least squares mean (LSM) of % change
from baseline in lumbar spine BMD at Month 18 was 6.77 (standard
error: 0.286) for SB16 and SB16. The LSM difference in the lumbar
spine BMD change for the full analysis set was –0.03% (90% CI
[–0.85, 0.79]) between SB16 + SB16 and DEN+DEN, and –0.52 (90% CI
[–1.48, 0.43]) between DEN+SB16 and DEN+DEN. The mean % change from
baseline in total hip BMD and femoral neck BMD at Month 18 were
comparable between treatment groups.
Details of the SB16 abstract presented at ECTS
2024 are as follows:
Presentation Title |
Presentation Details |
A Randomized, Double-blind, Phase III Study to Compare SB16
(Proposed Denosumab Biosimilar) to Reference Denosumab in Patients
with Postmenopausal Osteoporosis: 18-Month Results |
Session: Concurrent Oral Presentations 2: OsteoporosisDate/Time:
09:15- 09:25 CET, May 27, 2024Oral presentation number:
COP14Authors: Richard Eastell, Bente Langdahl, Yoon-Sok Chung,
Rafal Plebanski, Edward Czerwinski,Eva Dokoupilova, Jerzy Supronik,
Jan Rosa, Andrzej Mydlak, Anna Rowinska-Osuch, Ki-Hyun Baek,
Audrone Urboniene, Robert Mordaka, Sohui Ahn, Young Hee Rho, Jisuk
Ban |
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, endocrinology, and
gastroenterology. For more information, please visit:
www.samsungbioepis.com and follow us on social media – X,
LinkedIn.
1 Prolia is a trademark of Amgen.