Samsung Bioepis to Present Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024

• Post-hoc analysis of Phase 3 study to highlight transfusion avoidance results of SB12 compared to reference eculizumab-treated groups
  

INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that a post-hoc analysis of the Phase 3 clinical study results for EPYSQLI™ (SB12), a biosimilar to Soliris¹ (eculizumab), will be presented at the 29th European Hematology Association 2024 (EHA2024) Hybrid Congress held in Madrid, Spain and virtually, from June 13 to 16, 2024.

SB12 has shown equivalent efficacy with reference eculizumab (ECU) by lactate dehydrogenase (LDH) and comparable safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles in paroxysmal nocturnal hemoglobinuria (PNH) through the pivotal Phase 3 study.²

The post-hoc analysis of SB12 pivotal Phase 3 study presented at EHA2024 compared the proportion of patients remaining transfusion-free (“transfusion avoidance”) among those treated with SB12 or ECU, respectively. Eculizumab is known to significantly reduce hemolysis resulting in improvements in anemia as indicated by increased hemoglobin stabilization and reduced need for red blood cell (RBC) transfusions.³

“We are excited to present this data at EHA2024, that adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients,” said Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis. “We will continue to advance with our scientific research, publication and educational activities to bring more awareness of biosimilars for rare disease treatment and hope our study results serve as a guidance for clinicians.”

Details of the SB12 abstract are as follows:

• Abstract title: Transfusion Avoidance with EPYSQLI™(SB12), A Biosimilar to Reference Eculizumab: A Post-hoc Analysis from the Pivotal Phase 3 Study
• Abstract number: P1916
• Program type: e-Poster Presentation
• Authors: Jun Ho Jang, Jihye Park, Younsoo Kim, Jihyun Han and Paola Russo

In May 2023, European Commission (EC) approved SB12 as a biosimilar to Soliris (eculizumab) under the brand name EPYSQLI for the treatment of adults and children with PNH. In March 2024, EPYSQLI was granted an indication expansion for the treatment of adults and children with atypical haemolytic uremic syndrome (aHUS).⁴

About EPYSQLI (Eculizumab Biosimilar) in the European Union (EU)

EPYSQLI is indicated in adults and children for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). EPYSQLI must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with hematological disorders or renal disorders.

EPYSQLI EU Important Safety Information

The EU Summary of Product Characteristics for EPYSQLI includes the following Special warning and Precautions:

Meningococcal Infection

EPYSQLI increases patient's susceptibility to Meningococcal infection (Neisseria meningitidis). Meningococcal disease due to any serogroup may occur. To reduce the risk of infection, all patients must be vaccinated at least 2 weeks prior to receiving eculizumab unless the risk of delaying eculizumab therapy outweighs the risks of developing a meningococcal infection. Patients who initiate eculizumab treatment less than 2 weeks after receiving a tetravalent meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccines against serogroups A, C, Y and W 135 are recommended in preventing the commonly pathogenic meningococcal serogroups. Vaccines against serogroup B where available are also recommended. Patients must receive vaccination according to current national vaccination guidelines for vaccination use. 

Vaccination may further activate complement. As a result, patients with complement-mediated diseases, including PNH and aHUS, may experience increased signs and symptoms of their underlying disease, such as haemolysis (PNH) or TMA (aHUS). Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.

Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to official local guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in eculizumab-treated patients. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of warning signs and symptoms and steps taken to seek medical care immediately.

Other Systemic Infections

Patients may have increased susceptibility to other type of serious infections, especially with Neisseria and encapsulated bacteria.

Infusion Reactions

Administration of eculizumab may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis). Eculizumab administration should be interrupted in all patients experiencing severe infusion reactions and appropriate medical therapy administered.

Anticoagulant therapy

Treatment with EPYSQLI should not alter anticoagulant management.

PNH Laboratory Monitoring

PNH patients should be monitored for signs and symptoms of intravascular haemolysis, including serum lactate dehydrogenase (LDH) levels, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).

aHUS Laboratory Monitoring

aHUS patients receiving eculizumab therapy should be monitored for thrombotic microangiopathy by measuring platelet counts, serum LDH and serum creatinine, and may require dose adjustment within the recommended 14±2 day dosing schedule during the maintenance phase (up to every 12 days).

Treatment Discontinuation for PNH

If patients discontinue treatment with eculizumab they should be closely monitored for signs and symptoms of serious intravascular haemolysis.

Treatment Discontinuation for aHUS

If aHUS patients discontinue treatment with eculizumab, they should be monitored closely for signs and symptoms of severe thrombotic microangiopathy complications.

The most common adverse reaction observed with eculizumab treatment in clinical trials was found to be headache, whereas the most serious adverse reaction was found to be meningococcal infection. 

Refer to the Summary of Product Characteristics (SmPC) for EPYSQLI’s full safety information.

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, endocrinology, hematology and nephrology. For more information, please visit: www.samsungbioepis.com and follow us on social media – follow us on social media – X, LinkedIn.

References:

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1 Soliris is a trademark of Alexion Pharmaceuticals

2 Jang JH, Gomez RD, Bumbea H, Nogaieva L, Wong LLL, Lim SM, Kim Y, Park J. A phase III, randomised, double-blind, multi-national clinical trial comparing SB12 (proposed eculizumab biosimilar) and reference eculizumab in patients with paroxysmal nocturnal haemoglobinuria. EJHaem. 2022 Dec 20;4(1):26-36. doi: 10.1002/jha2.632. PMID: 36819188; PMCID: PMC9928655.

3 European Medicines Agency. Soliris Product Information. https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf. Accessed May 2024

4 European Medicines Agency. Epysqli Product Information. https://www.ema.europa.eu/en/documents/product-information/epysqli-epar-product-information_en.pdf. Accessed May 2024

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