Samsung Bioepis Presents Long-Term Safety Data of EPYSQLI™ (Eculizumab) in PNH at the European Hematology Association (EHA) Congress 2025

• Long-term follow-up of EPYSQLI’s Phase 3 study showed consistency of safety data between the initial 52-week period and the extended treatment period up to 158 weeks
• No new safety signals or fatal cases throughout the entire treatment period further supporting safety profile of EPYSQLI

INCHEON, Korea–(BUSINESS WIRE)– Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) today presented the long-term safety data of EPYSQLI™ (eculizumab; SB12), a biosimilar to Soliris¹, in paroxysmal nocturnal hemoglobinuria (PNH) at the European Hematology Association (EHA) Congress 2025 held at Milan, Italy from June 12 to 15.

EPYSQLI was approved by the European Commission (EC) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in May 2023 and March 2024, respectively².

The study assessed the long-term safety of EPYSQLI in PNH patients by evaluating the consistency of safety outcomes, particularly serious adverse events (SAEs) between the initial 52-week Phase 3 study period and the extended treatment (ET) period, spanning from 52 weeks to up to 158 weeks. The same maintenance dose of 900 mg EPYSQLI was administered every 2 weeks. A total of 46 patients from the Phase 3 study received ET. During ET, seven patients (15.2%) experienced a total of 14 SAEs with no occurrence of fatal cases, and all patients fully recovered without permanently discontinuing the treatment. The exposure-adjusted event rate (EAER) was comparable between initial 52-week period and ET period (EAER were 0.13 and 0.17, respectively), and there was no statistically difference between initial 52-week and ET period in EAER (p-value = 0.76). The study is consistent with the findings of the Phase 3 study with no newly identified safety signals and no fatal cases occurred throughout the entire treatment period with all SAEs resolving completely.

Details of the abstract are as follows³:

• Abstract title: Long-Term Safety of SB12 in Paroxysmal Nocturnal Hemoglobinuria: Up to 2-year Extension Treatment Safety Data
• Abstract number: PB2811
• Type: Publication Only
• Session title: Bone marrow failure syndromes incl. PNH – Clinical
• Author(s): Jun Ho Jang, Siook Baek, Yumin Baek, Jinah Jung, Ciprian Tomuleasa, Hanna Oliynyk, Theerin Lanamtieng, Soo Min Lim

Besides approval by the EC, EPYSQLI is also 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. In countries where EPYSQLI is approved and available, EPYSQLI may not be prescribed and/or dispensed for its unapproved other indications for which Soliris is approved.

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 is not approved for and should not be used for the treatment of generalised myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). 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

Due to its mechanism of action, the use of eculizumab increases the 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, W 135 are recommended in preventing the commonly pathogenic meningococcal serogroups. Vaccine against serogroup B where available is 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 guidance on the appropriate use of antibacterial agents. Cases of serious or fatal meningococcal infections have been reported in eculizumab-treated patients. Sepsis is a common presentation of meningococcal infections in patients treated with eculizumab. 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 these 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 eculizumab 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 headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was found to be meningococcal infection.

Refer to the Summary of Product Characteristics 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, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

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Contacts

MEDIA CONTACT
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com