U.S. License Holder:
Biogen / Bio-Thera
Date of License:
September-29-2023
Last Update:
Sep-30-2024
FDA-Approved Indications
TOFIDENCE (tocilizumab-bavi) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
Rheumatoid Arthritis (RA): Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs);
Giant Cell Arteritis (GCA): Adult patients with giant cell arteritis;
Polyarticular Juvenile Idiopathic Arthritis (PJIA): Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis;
Systemic Juvenile Idiopathic Arthritis (SJIA): Patients 2 years of age and older with active systemic juvenile idiopathic arthritis;
Coronavirus Disease 2019 (COVID-19): Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Tofidence (Biogen / Bio-Thera) (June-2024)