Samsung Bioepis Reveals Phase 3 Results of Soliris Biosimilar 'SB12' for the First Time: "Equivalence and Safety Confirmed"

Samsung Bioepis.

[Asia Economy Reporter Lee Gwan-joo] Samsung Bioepis announced on the 13th that it has unveiled for the first time the Phase 3 clinical trial results of Soliris biosimilar 'SB12 (generic name eculizumab)' at the European Hematology Association (EHA) Annual Congress held in Austria from the 9th to the 12th (local time).

SB12 is the seventh biosimilar developed by Samsung Bioepis and the first treatment for hematologic diseases. The original drug Soliris, developed by Alexion in the United States, is a treatment for rare refractory diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Last year, its global market sales reached $1.874 billion (approximately 2.3 trillion KRW).

Samsung Bioepis conducted a comparative study between SB12 and the original drug on PNH patients from July 2019 to October last year. According to the released abstract, Samsung Bioepis conducted the clinical trial by randomly assigning a total of 50 patients aged 18 and over. Ultimately, 46 patients completed the clinical trial, and the primary efficacy endpoint met the predefined clinical equivalence range. Among the secondary efficacy endpoints, the lactate dehydrogenase (LDH) values throughout the clinical trial period showed similar results, and treatment-emergent adverse events (TEAEs) were 72.3% for SB12 and 68.1% for the original drug.

Yoon-seok Oh, Executive Director and Head of the PE Team, the overall clinical trial leader, explained, “SB12 embodies the essential meaning of biosimilar development, which is to improve patient access to ultra-high-priced biopharmaceuticals,” adding, “Through the clinical trial, we were able to confirm safety and efficacy compared to the original drug.”

Soliris is a representative high-priced biopharmaceutical with an annual treatment cost reaching several hundred million KRW for adults. Considering this reality, Samsung Bioepis is also providing extended supply by offering SB12 free of charge for up to two years to domestic and international patients who participated in the clinical trial.

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