Samsung Bioepis Presents Totality-of-the-Evidence Supporting Extrapolation of EPYSQLI™ (SB12; Eculizumab)’s Indication, at the European Society of Paediatric Nephrology (ESPN) 2024

“Totality-of-the-evidence”, including analytical, non-clinical and clinical data, supports extrapolation of atypical hemolytic uremic syndrome (aHUS) indication for EPYSQLI

INCHEON, South Korea, Sept. 23, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today 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.

SB12, a biosimilar to reference eculizumab (ECU-RP), was approved by the European Commission (EC) in May 2023 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) based on the totality-of-the-evidence including analytical, non-clinical, and clinical data in healthy subjects and PNH patients². In March 2024, EC adopted an additional indication of atypical hemolytic uremic syndrome (aHUS) for SB12 based on the principle of extrapolation, also supported by the totality-of-the-evidence.

The totality-of-the-evidence presented at the ESPN 2024 compares SB12 to ECU-RP through an extensive analytical (more than 40 state-of-the-art assays) and non-clinical assessments. Clinical studies were taken to compare its pharmacokinetics (PK), pharmacodynamics (PD), efficacy, safety, tolerability, and immunogenicity in healthy subjects (Phase 1) and in complement inhibitor-naïve PNH patients. The structural, physicochemical, and biological characterization results demonstrated that SB12 is highly similar to ECU-RP. Through this evidence, the EC has adopted SB12’s usage in aHUS by principle of extrapolation.

“By demonstrating biosimilarity of SB12 to reference eculizumab through robust analytical, non-clinical and clinical data, we were able to justify totality-of-the-evidence supporting extrapolation of PNH data to aHUS indication. We are excited to be sharing this data at ESPN 2024 as it represents a significant milestone in our journey to provide quality-proven therapeutic options for patients with a serious and rare disease like aHUS,” said Hyejin Kim, Vice President and Medical & Lifecycle Safety Team Leader at Samsung Bioepis. “We will continue our educational efforts to help physicians understand the principle of extrapolation, since it is an important scientific concept in biosimilar development, allowing cost-effective development and timely access to safe and effective therapies to people who need it the most.”

Details of the SB12 abstract 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
  

Besides approval by the EC, SB12 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 for the treatment of patients with PNH and aHUS. In countries where SB12 is approved and available, SB12 may not be prescribed and/or dispensed for 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
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 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.

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

References:
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¹ Soliris is a trademark of Alexion Pharmaceuticals
² European Medicines Agency. Epysqli Product Information. https://www.ema.europa.eu/en/medicines/human/EPAR/epysqli Accessed September 2024