Omalizumab biosimilar（Celltrion）

奥马珠单抗生物类似药 (Celltrion)

Report date: 2026/04/30 20:00:20

Base Information

Drug NameOmalizumab biosimilar（Celltrion）
Drug Alias NameXolair biosimilar(Celltrion)OmlycloCT-P39
ClassificationBiologics > Protein drugs > Immunoglobulin > Antibody > Monoclonal antibody > Monoclonal antibody humanizedBiologics > Biosimilar
Mechanisms of ActionImmunosuppressantsImmunoglobulin E inhibitors
TargetsImmunoglobulin E
Therapy Area/IndicationsAllergic asthmaChronic rhinosinusitis with nasal polyps (CRSwNP)Food Hypersensitivity +[8] 
Global Approved IndicationsAllergic asthmaChronic rhinosinusitis with nasal polyps (CRSwNP)Food Hypersensitivity +[7] 
Approved Indications in ChinaN/A
Original Approved Country/TerritoryEU
Original Approved Date2024/05/16
Country/TerritoryCanadaUnited StatesPoland +[5] 
CombinationsNo
Global Highest StatusApproved
Highest Status in ChinaN/A
Originator CompaniesCelltrion Inc
China Registration ClassN/A

Develop Information

Active CompaniesCelltrion Healthcare Hungary KftCelltrion Inc
Inactive CompaniesN/A
Active IndicationsAllergic asthmaChronic rhinosinusitis with nasal polyps (CRSwNP)Food Hypersensitivity +[8] 
Inactive IndicationsN/A

Other Information

ATC CodeR03DX05
Related LinksN/A