Eculizumab biosimilar (Samsung Bioepis)

依库珠单抗生物类似药 (Samsung Bioepis)

Report date: 2024/07/23 09:39:03

Base Information

Drug NameEculizumab biosimilar (Samsung Bioepis)
Drug Alias Name依库珠单抗生物仿制药 (Samsung Bioepis)EPYSQLIEpysqliSB-12AM004 +[7] 
ClassificationBiologics > BiosimilarBiologics > Protein drugs > Immunoglobulin > Antibody > Monoclonal antibody > Monoclonal antibody humanized
Mechanisms of ActionComplement C5 inhibitors
TargetsComplement C5
Therapy Area/IndicationsHemoglobinuria, ParoxysmalAtypical Hemolytic Uremic Syndrome
Global Approved IndicationsHemoglobinuria, ParoxysmalAtypical Hemolytic Uremic Syndrome
Approved Indications in ChinaN/A
Original Approved Country/TerritoryEU
Original Approved Date2023/05/26
Country/TerritoryUnited StatesUkraineTaiwan +[13] 
CombinationsNo
Global Highest StatusApproved
Highest Status in ChinaDiscontinued
Originator CompaniesSamsung Bioepis Co Ltd
China Registration ClassN/A

Develop Information

Active CompaniesSamsung Bioepis UK LtdSamsung Bioepis Nl BvSamsung Bioepis Co Ltd +[4] 
Inactive CompaniesPpd Pharmaceutical Development (Beijing) Co LtdSamsung Biologics Co Ltd
Active IndicationsHemoglobinuria, ParoxysmalAtypical Hemolytic Uremic Syndrome
Inactive IndicationsN/A

Other Information

ATC CodeL04AJ01
Related LinksN/A