Fresenius Launches Groundbreaking Tyenne® (tocilizumab-aazg) a Subcutaneous Formulation

Fresenius introduced Tyenne® (tocilizumab-aazg), the first FDA-approved tocilizumab biosimilar available in both intravenous (IV) and subcutaneous formulations.

This subcutaneous version, now offered in a prefilled syringe and an autoinjector, aims to enhance patient access to affordable treatment options in the U.S., particularly for those managing chronic autoimmune diseases.

Tyenne® is a biosimilar to Actemra® and acts as an Interleukin-6 (IL-6) receptor antagonist. While it provides an effective treatment for autoimmune diseases, it carries a boxed warning for serious infections, including tuberculosis, invasive fungal infections, and other opportunistic infections. Tyenne® should not be used in patients with a known allergy to tocilizumab products.

Tyenne® was previously launched in an IV formulation. It is the third biosimilar from Fresenius available in the U.S. and the second in its immunology portfolio. 

The subcutaneous version offers patients an additional self-administered option for the treatment of conditions such as rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

Trial data demonstrated that Tyenne® offers comparable safety and tolerability to its reference product, Actemra® (tocilizumab).