Intravenous Formulation of Biosimilar Tyenne Now Available

Tyenne^® (tocilizumab-aazg), a biosimilar to Actemra^® (tocilizumab), is now available in an intravenous (IV) presentation (80mg/4mL, 200mg/10mL, and 400mg/20mL single-dose vials for further dilution prior to IV infusion).

Tyenne, an interleukin-6 receptor antagonist, is indicated for the treatment of:

• Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs;
• Adults with giant cell arteritis; and
• Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis.

A biosimilar is a biological product that is approved based on a demonstration that it is highly similar to an already-approved biological product with no clinically meaningful differences in safety and efficacy from the reference product. 

In March 2024, Tyenne received approval from the Food and Drug Administration for both IV and subcutaneous (SC) administration based on data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04512001). The trial compared tocilizumab-aazg to an EU-approved tocilizumab in patients with moderately to severely active rheumatoid arthritis. Findings showed both products were equally effective and safe.

The SC presentations of Tyenne are expected to launch later this year.