INCHEON, Korea – June 8 2023 – Samsung Bioepis Co., Ltd. today announced results from the population PK/PD/efficacy modeling of SB12, a biosimilar to Soliris (eculizumab)² , and reference eculizumab at the 28th European Hematology Association 2023 (EHA2023) Hybrid Congress held in Frankfurt, Germany and virtually, from June 8 to 11, 2023. The modeling analysis showed similarities of PK, PD, and efficacy profiles between SB12 and reference eculizumab in pooled population of healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH). 

SB12 was granted marketing authorization by the European Commission (EC) on May 26, 2023 under the brand name EPYSQLI™, as a biosimilar to Soliris for treatment of adult and children patients with PNH.³ 

The purpose of the modeling was to describe and compare PK, PD, and efficacy of SB12 and reference eculizumab, and find clinically significant covariate relationships. The PK, PD and efficacy data of SB12 and reference eculizumab were obtained from Phase 1 study and Phase 3 study.

The population modeling showed similarities in PK, PD and efficacy between SB12 and reference eculizumab in pooled population of healthy subjects and PNH patients, supporting the totality of evidence on biosimilarity for SB12.

Details of the SB12 abstract are as follows:

• Abstract title: Population Pharmacokinetic/Pharmacodynamic/Efficacy Modeling of SB12 (proposed eculizumab biosimilar) and Reference Eculizumab

• Abstract number: PB2051

• Program type: Publication Only

• Authors: Hyuna Lee, et al. 

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EPYSQLI™ is indicated in adults and children for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with hemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history. EPYSQLI must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with hematological disorders.

The EU Summary of Product Characteristics for EPYSQLI includes the following Special warning and Precautions: 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, W 135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups. Patients must receive vaccination according to current national vaccination guidelines for vaccination use. 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. 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.

Patients may have increased susceptibility to other type of serious infections, especially with Neisseria and encapsulated bacteria. Treatment with EPYSQLI should not alter anticoagulant management. Administration of EPYSQLI may result in infusion reactions or immunogenicity that could cause allergic or hypersensitivity reactions (including anaphylaxis).

The most common adverse reaction observed with eculizumab treatment in clinical trials was headache, and the most serious adverse reaction was meningococcal sepsis. 

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

Jane Chung, ejane.chung@samsung.com

Anna Nayun Kim, nayun86.kim@samsung.com

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