Yearly 50 Billion 'Soliris'... Samsung Bioepis Attempts to Reduce Burden with Similar Drug

Intractable Rare Blood Disorder Treatment 'Soliris'
Lifetime Administration Required, Annual Cost 400-500 Million KRW

Samsung Bioepis Reveals Additional Phase 3 Results for 'SB12'
Application for Approval in Europe and Korea Submitted

A Samsung Bioepis representative is presenting the clinical analysis results of 'SB12' through a poster presentation at the American Society of Hematology (ASH) conference held in New Orleans, USA, from the 10th to the 13th (local time). (Photo by Samsung Bioepis)

[Asia Economy Reporter Chunhee Lee] Samsung Bioepis has released sensitivity analysis data demonstrating the robustness of equivalence to the original for 'SB12,' a biosimilar (biopharmaceutical generic) under development for the treatment of the intractable rare blood disorder drug 'Soliris' (generic name eculizumab).

Samsung Bioepis announced on the 13th that it presented these data on SB12 at the annual meeting of the American Society of Hematology (ASH), held from the 10th to the 13th (local time) in New Orleans, USA. Founded in 1958, ASH is an academic organization with over 18,000 members from 100 countries. It holds its annual scientific meeting every December.

Soliris is a treatment for intractable rare blood disorders developed by Alexion in the United States. Its primary indication is paroxysmal nocturnal hemoglobinuria (PNH), a condition caused by the destruction of red blood cells in the blood. It is also used for atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG). However, the only current cure for PNH is bone marrow transplantation. Soliris is a drug that prevents the disease from worsening, so continuous administration is necessary. The annual treatment cost is known to reach 400 to 500 million KRW.

As of last year, Soliris has grown into a blockbuster drug with global sales of $1.874 billion (approximately 2.45 trillion KRW). This success is considered the driving force behind AstraZeneca's acquisition of Alexion in 2020 for $39 billion (approximately 51 trillion KRW), the largest merger and acquisition (M&A) deal in the pharmaceutical and biotech industry. This is also why Samsung Bioepis entered the biosimilar development race for Soliris, whose patent is nearing expiration.

Samsung Bioepis previously demonstrated clinical medical equivalence of SB12 to the original in a Phase 3 clinical trial conducted from August 2019 to October last year involving PNH patients. At this year's ASH, the company presented statistical analysis results to confirm the robustness of the main conclusions of that clinical trial through a poster session.

The primary efficacy results measured in the SB12 Phase 3 trial were the 'lactate dehydrogenase (LDH) level at week 26 after prescription' and the 'time-adjusted LDH area under the effect curve (AUEC)' from weeks 14 to 26 and weeks 40 to 52. LDH is an enzyme abundant in red blood cells, and since LDH is released into the blood when red blood cells are destroyed in PNH, it is used as a key biomarker for diagnosing PNH.

Samsung Bioepis conducted two statistical analysis methods for the sensitivity analysis of the primary efficacy endpoint: 'complete case analysis,' which includes only subjects with no missing data, and the 'multiple imputation method,' one of the methods for handling missing data.

According to the released abstract, Samsung Bioepis obtained consistent conclusions with the primary efficacy results in both analysis methods, verifying the robustness of the clinical trial results and reaffirming the clinical medical equivalence between SB12 and Soliris.

A Samsung Bioepis official stated, “SB12 embodies the essential meaning of biosimilar development, which is to expand patient access to ultra-high-cost drugs,” adding, “We will continue our efforts to provide more treatment opportunities to patients suffering from rare diseases.” Since it is an expensive treatment, Samsung Bioepis is also implementing a plan to provide SB12 free of charge for up to two years to clinical trial participants.

Currently, Samsung Bioepis has applied for marketing authorization of SB12 to the European Medicines Agency (EMA) and the Korea Ministry of Food and Drug Safety. Although Amgen's 'ABP959' and Isu Abxis's 'ISU305' are also under development, there are no internationally approved biosimilars of Soliris yet, and Samsung Bioepis aims to be the world's first biosimilar.

This content was produced with the assistance of AI translation services.