FDA Approves Second Biosimilar of Actemra

The FDA has approved Fresenius Kabi’s Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Genentech’s Actemra. It was approved to treat patients with several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

The approval is based on analytical similarity and clinical data used to demonstrate similar pharmacokinetic, efficacy, safety, tolerability, and immunogenicity to the reference product, with and without switch from Actema to Tyenne.

Tyenne has launched globally in more than 10 countries. But Fresenius Kabi officials indicated in a press release that the launch date in the United States depends on a patent settlement agreement with Genentech, which is confidential.

It could be a crowded market when Tyenne launches. Although not the first biosimilar approved to reference Actemra, Tyenne is the first to have both IV and subcutaneous options approved by the FDA. In September 2023, the FDA approved Biogen’s IV formulation biosimilar, Tofidence. Tofidence is not yet available on the U.S. market.

Tyenne, Tofidence and Actemra are interleukin-6 (IL-6) receptor antagonists that target specific inflammatory proteins to suppress the immune system.

Related: Celltrion USA Seeks Approval for Actemra Biosimilar

Additionally, in January 2024, Celltrion USA completed its biologic license application to the FDA for CT-P47, its Actemra biosimilar. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations.

The average monthly cost of Actemra administered via IV ranges from about $2,308 to $4,616, depending on which dose a person receives, according to a Genentech spokesperson. The average monthly cost of Actemra administered subcutaneously ranges from about $2,478 to $4,956 depending on how frequently a person takes it, the dose varies depending on the person’s weight.