Samsung Bioepis Supports EPYSQLI™ Extrapolation at ESPN 2024

On September 23, 2024, Samsung Bioepis Co., Ltd. showcased comprehensive evidence supporting the use of EPYSQLI™ (SB12), a biosimilar to Soliris (eculizumab), for treating atypical hemolytic uremic syndrome (aHUS) at the 56th European Society for Paediatric Nephrology (ESPN 2024) held in Valencia, Spain from September 24 to 27, 2024.

SB12, being a biosimilar to the reference drug eculizumab (ECU-RP), received approval from the European Commission (EC) in May 2023 for treating paroxysmal nocturnal hemoglobinuria (PNH). This approval was based on a comprehensive evaluation of analytical, non-clinical, and clinical data obtained from studies involving both healthy subjects and patients suffering from PNH. In March 2024, the EC approved an additional indication for SB12 for the treatment of aHUS, utilizing the principle of extrapolation, which was again supported by a thorough body of evidence.

At ESPN 2024, the totality of evidence comparing SB12 to ECU-RP was presented, encompassing extensive analytical methods (over 40 state-of-the-art assays) and non-clinical assessments. Clinical trials were conducted to compare the pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, tolerability, and immunogenicity of SB12 in both healthy individuals (Phase 1) and complement inhibitor-naïve PNH patients. The results from structural, physicochemical, and biological characterizations indicated that SB12 is remarkably similar to ECU-RP. This comprehensive evidence led the EC to adopt SB12 for use in treating aHUS based on extrapolation principles.

Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis, expressed enthusiasm about sharing this data at ESPN 2024, highlighting it as a significant milestone in providing quality therapeutic options for patients with serious and rare diseases like aHUS. Kim emphasized the ongoing educational efforts to help physicians understand the principle of extrapolation, which is crucial in biosimilar development, enabling cost-effective development and timely access to safe and effective therapies.

The details of the SB12 abstract presented are as follows:
- Abstract title: Totality of the evidence supports extrapolation of atypical hemolytic uremic syndrome (aHUS) indication for EPYSQLI™ (biosimilar to reference eculizumab)
- Abstract number: P2.077
- Authors: David Kavanagh, Eleni Gavriilaki, Jihyun Han, Jake Yongkwon Lee, Hyejin Kim, Paola Russo

In addition to EC approval, SB12 has also been approved by the U.S. Food and Drug Administration (FDA) and Korea’s Ministry of Food and Drug Safety (MFDS) as a biosimilar to Soliris for treating patients with PNH and aHUS. In regions where SB12 is approved and available, it may not be prescribed or dispensed for other indications for which Soliris is approved.

EPYSQLI is indicated for adults and children in the treatment of PNH and aHUS. However, it is not approved for, and should not be used in the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Administration of EPYSQLI must be done by a healthcare professional under the supervision of a physician experienced in managing patients with hematological or renal disorders.

Established in 2012, Samsung Bioepis is a biopharmaceutical company dedicated to making healthcare accessible to all. Through product development innovations and a strong commitment to quality, the company aims to become the leading biopharmaceutical company globally. Samsung Bioepis is advancing a broad pipeline of biosimilar candidates covering various therapeutic areas, including immunology, oncology, ophthalmology, endocrinology, hematology, and nephrology.