New phase III study of SB 12 (eculizumab biosimilar) showed equivalence to Soliris, at the European Hematology Association (EHA) Congress 2022.- Samsung Bioepis.
Samsung Bioepis Co., Ltd. announced that SB 12, a proposed biosimilar to Soliris (eculizumab), showed clinical equivalence in efficacy, safety, PK, PD and immunogenicity between SB 12 and reference eculizumab in patients with PNH.
The Phase III 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 (IgG2/4?) 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 disease.
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 SB 12 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 SB 12 and reference eculizumab (SB 12 – 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 SB 12 and reference eculizumab (SB 12/ECU: 1.08, 90% CI [0.95, 1.23]) lied within the pre-defined equivalence margin – indicating that the SB 12 was bioequivalent to the reference eculizumab.
Samsung Bioepis hopes to file for approval in the US in the coming months. It will be in competition with Amgen for first approval of a biosimilar of eculizumab although Amgen has a deal with Alexion not to launch the biosimilar until 2025.
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