FDA Approves Tocilizumab Biosimilar for IV and Subcutaneous Administration

The Food and Drug Administration (FDA) has approved Tyenne^® (tocilizumab-aazg), the first biosimilar to Actemra^® (tocilizumab) for both intravenous (IV) and subcutaneous (SC) administration.

Tyenne, an interleukin-6 (IL-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 (DMARDs);
• 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. The approval of Tyenne was supported by data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04512001) that compared tocilizumab-aazg to an EU-approved tocilizumab in patients with moderately to severely active rheumatoid arthritis. 

Findings showed both products were equally effective based on clinically relevant decreases from baseline in Disease Activity Score-28 Joint Count-erythrocyte sedimentation rate at week 24 (primary endpoint). Similarity was also demonstrated with regard to safety and immunogenicity. 

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the US is a moment of great pride for Fresenius Kabi,” said Dr Michael Schönhofen, Fresenius Kabi President Biopharma. “The FDA’s approval of our tocilizumab biosimilar is a breakthrough in bringing high-quality, affordable, and accessible autoimmune treatment options to patients and health care providers.”

Tyenne is supplied as a 20mg/mL single-dose vial (80mg/4mL, 200mg/10mL, or 400mg/20mL) for further dilution prior to IV infusion. It is also available as a ready-to-use, single-dose prefilled syringe (162mg/0.9mL) and a single-dose prefilled autoinjector (162mg/0.9mL) for SC injection.

In September 2023, the FDA had approved the first biosimilar to Actemra, Tofidence^™ (tocilizumab-bavi). This product is administered as an IV infusion.