• Phase 3 study demonstrated clinical equivalence in efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB12 compared to reference eculizumab in paroxysmal nocturnal hemoglobinuria (PNH) patients
  • Abstract and e-poster are available at EHA2022 website

INCHEON, Korea I June 10, 2022 I Samsung Bioepis Co., Ltd. today announced that SB12, a proposed biosimilar to Soliris1 (eculizumab), showed clinical equivalence in efficacy, safety, PK, PD and immunogenicity between SB12 and reference eculizumab in patients with PNH. The Phase 3 study results are presented as an e-poster at the 27th European Hematology Association 2022 (EHA2022) Hybrid Congress held in Vienna, Austria and virtually, from June 9 to 12, 2022.

Soliris (eculizumab) is a humanised monoclonal (IgG2/4κ) antibody produced in NS0 cell line by recombinant DNA technology which is currently used in adults and children for the treatment of PNH and atypical haemolytic uremic syndrome (aHUS) and in adults for refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive and neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease2.

The objective of the study was to determine clinical efficacy by evaluating the level of lactate dehydrogenase (LDH), safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB12 and reference eculizumab (ECU). The primary endpoints were LDH level at Week 26 and time-adjusted area of under the effect curve (AUEC) of LDH from Week 14 to Week 26 and from Week 40 to Week 52. The results showed that 95% CI of mean difference in LDH level at Week 26 between SB12 and reference eculizumab (SB12 – reference eculizumab: 34.48, 95% CI [−47.66, 116.62]) lied within the pre-defined equivalence margin. In addition, the 90% CI of ratio of time-adjusted AUEC of LDH between SB12 and reference eculizumab (SB12/ECU: 1.08, 90% CI [0.95, 1.23]) lied within the pre-defined equivalence margin – indicating that the SB12 was bioequivalent to the reference eculizumab.

“We are very pleased to be sharing our Phase 3 study of SB12, our first hematology and orphan biologic therapy, at EHA 2022,” said Luke Oh, Ph.D., Vice President and Product Evaluation Team Leader at Samsung Bioepis. “We are fully aware that rare diseases, such as PNH pose many, but unique, challenges to patients and their families. We will continue our journey to transform the way biologic therapies are brought to patients and enhance the lives of patients, including those with rare diseases, through our pioneering and innovative use of science and technology.”

Details of the SB12 abstract are as follows:

  • Abstract title: A Phase III Randomized Clinical Trial Comparing SB12 (Proposed Eculizumab Biosimilar) With Reference Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria
  • Abstract number: P829
  • Program type: Poster presentation
  • Date and time: June 10, 2022 (09:00 CEST)
  • Authors: Jun Ho Jang, et al.

About the SB12 Phase 3 study

The study is a randomized, double-blind, multicenter, cross-over study in 50 patients to treatment sequence I (TS1SB12 to reference eculizumab, n=25) or II (TS2: reference eculizumab to SB12, n=25). Patient received 600 mg of SB12 (TS1) or reference eculizumab (TS2) intravenously every week for first 4 weeks (initial phase) and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter (maintenance phase). The treatment was switched to reference eculizumab (TS1) or SB12 (TS2) at Week 26, and switched treatment was provided until Week 50.

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 – Twitter, LinkedIn.


1 Soliris is a trademark of Alexion Pharmaceuticals, Inc.

2 European Medicines Agency. Soliris Product Information. https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf

SOURCE: Samsung Bioepis