戈利木单抗注射液（50mg/4mL）-IMMGOLIS®GOTENFIA®-Bio-Thera Solutions, Ltd.

TBD®Golimumab (IV)（ 50 mg/4 mL）

Please use it under the supervision of a healthcare professional. IV is only approved in China now.

IMMGOLIS/Gotenfia is a proposed biosimilar to Simponi® which is a human IgG1 monoclonal antibody that targets tumor necrosis factor alpha (TNF- α), a pro-inflammatory molecule. Binding of golimumab to TNF-α results in reductions in C-reactive protein (CRP), Interleukin 6 (IL-6), Intercellular Adhesion Molecule 1 (ICAM-1), Matrix Metalloproteinase 3 (MMP-3), and Vascular Endothelial Growth Factor (VEGF), all inflammatory markers. IMMGOLIS™ (golimumab-sldi) and IMMGOLIS INTRI™ (golimumab-sldi) are the first biosimilars to Simponi® and Simponi Aria® in the US. Gotenfia® is the second approved golimumab biosimilar in the EU.

药品说明书

TBD®

In the US, IMMGOLIS® (ustekinumab-hmny) Injection is indicated for the treatment of adults patients with moderately to severely active rheumatoid arthritis in combination with methotrexate, and for the treatment of adult patients with moderately to severely active ulcerative colitis. The FDA also approved IMMGOLIS INTRI (golimumab-sldi), a biosimilar to Simponi Aria® (golimumab), for the treatment of adult patients with moderately to severely active RA in combination with methotrexate.

In the Europe, GOTENFIA® is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, polyarticular juvenile idiopathic arthritis and ulcerative colitis

TBD®Golimumab (IV)（ 50 mg/4 mL）

Please use it under the supervision of a healthcare professional. IV is only approved in China now.