Samsung Epis's Soliris biosimilar bioequivalent to original

Makes a poster presentation about the study to the American Society of Hematology Annual Meeting

Demonstrates bioequivalence to the original through additional analysis

Study results that show Samsung Bioepis’s Soliris biosimilar is bioequivalent to the original drug have been presented.

 

On the 13th, the company announced that its biosimilar, SB12 has demonstrated equal effect to its original drug Soliris at the American Society of Hematology (ASH) Annual Meeting that is being held in New Orleans.

 

Soliris is a rare disease treatment used to treat incurable rare diseases like paroxysmal nocturnal hemoglobinuria (PNH) that was developed by the US pharmaceutical company Alexion.

 

SB12 is a biopharmaceutical drug developed using the same active ingredient contained in Soliris, eculizumab.

 

Samsung Bioepis presented statistical analysis results in the form of a poster to add credibility to the clinical results through additional analysis of its Phase III clinical trial.

 

The company had previously demonstrated the bioequivalence of SB12 to Soliris in terms of clinical efficacy and safety through a Phase III trial that had been conducted from 2019 to last year.

 

The primary efficacy endpoint of the SB12 Phase III trial was the level of lactate dehydrogenase (LDH) at Week 26 and the time-adjusted area of under the effect curve (AUEC) of LDH from Week 14 to Week 26 and from Week 40 to Week 52.

 

The red blood cell of patients are destroyed and LDH is released into the blood when a patient develops PNH.

 

LDH is one of the biomarkers that can diagnose this.

 

Elevated LDH levels are usually associated with liver disease and increased fatigue, etc.

 

The trial looked at the time-adjusted area under the effect curve (AUEC) of LDH from Week 14 to Week 26 and from Week 40 to Week 52 to observe whether these levels were similar to the original.

 

Results showed that the LDH level lay within the pre-defined equivalence margin, indicating that the SB12 was bioequivalent to the original drug.

 

Samsung Bioepis conducted a further sensitivity analysis to add reliability to the accuracy of the results of the Phase III trial.

 

Statistical analysis derived the same conclusions as the primary efficacy endpoint results that were observed in the Phase III trial.

 

An official from Samsung Bioepis said, “SB12 contains the core purpose of biosimilars that seek to expand patient access to expensive medicines.

 

We will continue to make efforts to provide more treatment opportunities to patients suffering from rare diseases.”