U.S. License Holder:
Biogen / Bio-Thera
Date of License:
September-29-2023
Last Update:
July-08-2024
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);
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.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In The E.U.
Tofidence (Biogen / Bio-Thera) (June-2024)