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

• Follow-up results from Phase 3 study on SB16: switching period up to Month 18
• Study shows SB16 comparable with reference denosumab before and after switching in terms of efficacy, pharmacokinetics, pharmacodynamics, safety and immunogenicity

INCHEON, Korea, May 27, 2024 (GLOBE NEWSWIRE) -- 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: Osteoporosis Date/Time: 09:15- 09:25 CET, May 27, 2024 Oral presentation number: COP14 Authors: 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.

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¹ Prolia is a trademark of Amgen.

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