Golimumab biosimilar (Bio-thera)

戈利木单抗生物类似药 (百奥泰)

Report date: 2026/05/20 20:02:01

Base Information

Drug NameGolimumab biosimilar (Bio-thera)
Drug Alias NameSimponi I.V (Bio-thera)GotenfiaIMMGOLISIMMGOLIS INTRIImmgolis +[8] 
ClassificationBiologics > Protein drugs > Immunoglobulin > Antibody > Monoclonal antibody > Monoclonal antibody humanBiologics > Biosimilar
Mechanisms of ActionTumor necrosis factor α inhibitors
TargetsTumor necrosis factor α
Therapy Area/IndicationsAxial SpondyloarthritisColitis, UlcerativeArthritis, Rheumatoid +[6] 
Global Approved IndicationsAxial SpondyloarthritisColitis, UlcerativeArthritis, Rheumatoid +[5] 
Approved Indications in ChinaN/A
Original Approved Country/TerritoryEU
Original Approved Date2026/02/10
Country/TerritoryCzechiaBulgariaUnited States +[8] 
CombinationsNo
Global Highest StatusApproved
Highest Status in ChinaNDA/BLA
Originator CompaniesBio-Thera Solutions Ltd
China Registration ClassN/A

Develop Information

Active CompaniesPharmaparkBio-Thera Solutions LtdStada Arzneimittel Ag +[4] 
Inactive CompaniesN/A
Active IndicationsAxial SpondyloarthritisColitis, UlcerativeArthritis, Rheumatoid +[6] 
Inactive IndicationsN/A

Other Information

ATC CodeL04AB06
Related LinksN/A