Samsung Bioepis Completes Phase 3 Clinical Trial for Rare Blood Disorder Treatment Biosimilar 'SB12'

Samsung Bioepis New Headquarters Exterior (Photo by Samsung Bioepis)

[Asia Economy Reporter Chunhee Lee] The global Phase 3 clinical trial of Samsung Bioepis's rare blood disorder treatment biosimilar (biopharmaceutical generic) 'SB12 (generic name 'Eculizumab')' has been completed.

Samsung Bioepis announced on the 27th that after the last patient visit for the clinical trial of the 'Soliris' biosimilar SB12, the related information was updated on the global clinical trial website 'ClinicalTrials' on the 25th. Samsung Bioepis has been conducting a Phase 3 clinical trial since August 2019 involving 50 patients with paroxysmal nocturnal hemoglobinuria (PNH) from 8 countries including Korea to compare the efficacy and safety between SB12 and the original drug Soliris.

Soliris is a rare disease treatment developed by the US pharmaceutical company Alexion for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome (aHUS). The domestic reimbursement ceiling is as high as 5.13 million KRW, and the annual treatment cost for adults according to dosage and administration reaches several hundred million KRW, making it one of the representative high-priced biopharmaceuticals. The annual global sales amount to 4.0642 billion USD (approximately 4.7429 trillion KRW).

A Samsung Bioepis official stated, “Through the development of SB12, we will strive to improve patient accessibility to ultra-high-priced biopharmaceuticals and help address the unmet medical needs, which is the essential significance of biosimilar development.”

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