Pegfilgrastim biosimilar (Fresenius SE)

非格司亭生物类似药 (Fresenius SE)

Report date: 2022/09/05 09:40:33

Base Information

Drug NamePegfilgrastim biosimilar (Fresenius SE)
Drug Alias NamePegfilgrastim-FPGK非格司亭生物仿制药 (Fresenius SE)培非格司亭生物仿制药 (Fresenius SE)StimufendMSB-11455
ClassificationBiologics > BiosimilarBiologics > Protein drugs > Recombinant protein > Recombinant cytokines
Mechanisms of ActionHaematopoiesis stimulantsColony stimulating factor 3 receptor agonists
TargetsColony stimulating factor 3 receptor
Therapy Area/IndicationsChemotherapy-Induced Febrile NeutropeniaFebrile NeutropeniaNeutropenia
Global Approved IndicationsChemotherapy-Induced Febrile NeutropeniaFebrile NeutropeniaNeutropenia
Approved Indications in ChinaN/A
Original Approved Country/TerritoryEU
Original Approved Date2022/03/28
Country/TerritoryUnited StatesNew ZealandAustralia +[4] 
CombinationsNo
Global Highest StatusApproved
Highest Status in ChinaN/A
Originator CompaniesMerck Serono
China Registration ClassN/A

Develop Information

Active CompaniesFresenius Kabi Usa LlcFresenius Kabi Deutschland Gmbh
Inactive CompaniesFresenius Kabi Swissbiosim Gmbh
Active IndicationsChemotherapy-Induced Febrile NeutropeniaFebrile NeutropeniaNeutropenia
Inactive IndicationsN/A

Other Information

ATC CodeL03AA13
Related LinksN/A