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A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris, and US Sourced Soliris) in Healthy Subjects

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Trial Profile

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris, and US Sourced Soliris) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 24 Sep 2024

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At a glance

  • Drugs Eculizumab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Pharmacokinetics
  • Sponsors Samsung Bioepis

Most Recent Events

  • 23 Sep 2024 According to a Samsung Bioepis media release , the company presented the totality-of-the-evidence supporting extrapolation of atypical hemolytic uremic syndrome (aHUS) indication on EPYSQLI(SB12), a biosimilar to Soliris1 (eculizumab), at the 56th European Society for Paediatric Nephrology (ESPN 2024). The congress will be taking place from September 24 to 27, 2024 in Valencia, Spain.
  • 22 Jul 2024 According to a Samsung Bioepis media release, based on data form NCT03722329 and NCT04058158, the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for EPYSQLI (eculizumab-aagh) as a biosimilar to Soliris1 (eculizumab). EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
  • 15 Jun 2023 Results assessing Population Pharmacokinetic/Pharmacodynamic/Efficacy Modeling of Sb12 (Proposed Eculizumab Biosimilar) and Reference Eculizumab presented at the 28th Congress of the European Haematology Association

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