Drug intelligence / Profile preview

SB12

Development stage
Approved
Lead developer
Samsung Bioepis
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

SB12 is a biosimilar of eculizumab, a humanized monoclonal antibody that targets complement protein C5. By binding to C5, it inhibits the terminal complement cascade and prevents the formation of the membrane attack complex, thereby reducing hemolysis in diseases characterized by uncontrolled complement activation. SB12 is developed by Samsung Bioepis and has been authorized in Europe under the brand name EPYSQLI as a biosimilar to Soliris (eculizumab). Its primary indications include paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), with development also targeting other conditions for which reference eculizumab is approved such as generalized myasthenia gravis and neuromyelitis optica spectrum disorder[1][2][3][4][5][7][8].

Brand names
EPYSQLI
Other names
eculizumab biosimilarSoliris biosimilar
02

Targets

C5

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