FDA Approves Tocilizumab-aazg as Biosimilar to Actemra for Multiple Indications


Tocilizumab-aazg (Tyenne; Fresenius Kabi) is the first approved biosimilar to tocilizumab (Actemra; Genentech) as both intravenous and subcutaneous.

The FDA approved tocilizumab-aazg (Tyenne; Fresenius Kabi), which is a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.

The FDA approved the first tocilizumab biosimilar (tocilizumab-bavi; Tofidence from Biogen) in September 2023.2 However, tocilizumab-aazg is the first approved biosimilar to tocilizumab with both intravenous (IV) and subcutaneous formulations, according to a press release from the company.1

Medical concept of FDA approved. Food and drugs administration quality control. | Image Credit: wladimir1804 - stock.adobe.com

Image Credit: wladimir1804 - stock.adobe.com

“Fresenius Kabi is leading the way as the first company to receive FDA approval forboth IV and subcutaneous formulations of its tocilizumab biosimilar,” Fabrice Romanet, senior vice president of innovation and development at Fresenius Kabi, said in the press release.1

Key Takeaways

  1. Fresenius Kabi received FDA approval for tocilizumab-aazg (Tyenne) for treating various inflammatory and immune diseases.
  2. This is the first biosimilar to tocilizumab available in both intravenous (IV) and subcutaneous formulations
  3. Tyenne is approved for:
    1. Rheumatoid arthritis
    2. Giant cell arteritis
    3. Polyarticular juvenile idiopathic arthritis
    4. Systemic juvenile idiopathic arthritis

The biosimilar is an IL-6 receptor antagonist and it will be available in prefilled syringes, pen injectors, and vial presentations. Serious infections have occurred for individuals receiving the product, including tuberculosis, bacterial, invasive fungal, viral, and other infections, according to the press release.1

The IV formulation for rheumatoid arthritis completed 5 double-blinded, controlled studies, where individuals received at least 1 dose of the drug. Of 4009 individuals, 3577 received the treatment for at least 6 months, 3309 for 1 years, 2954 for 2 years, and 2189 for 3 years, according to the prescribing information. The proportion of individuals who discontinued due to adverse reactions was 5% for tocilizumab-aazg of 3% for those who were treated with the placebo, with the most common adverse reactions being hepatic transaminase values and serious infections.3

For the subcutaneous treatment with rheumatoid arthritis, tocilizumab-aazg underwent 2 double-blinded, controlled studies, according to the prescribing information. The first study was a non-inferiority trial to compare the efficacy and safety of tocilizumab-aazg 162 mg every week subcutaneously and 8 mg/kg intravenously every 4 weeks in 1262 adults. The second study was a placebo-controlled superiority study to evaluate the safety and efficacy of 162 mg every other week subcutaneously or the placebo in 656 individuals.3

The safety profile was consistent with the IV tocilizumab-aazg safety profile, except the subcutaneous injection included more common injection site reactions.3

Furthermore, there were additionally studies for the subcutaneous and IV in giant cell arteritis, juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis that were included on the prescribing information.3 Additional information about the clinical trials can be found on the prescribing information.

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in United States is a moment of great pride for Fresenius Kabi. 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,” Michael Schönhofen, president of Biopharma at Fresenius Kabi, said in a press release.1

The biosimilar has launched in more than 10 countries, with more planned between 2024 and 2025, according to the press release. It is the third biosimilar from the company, following pefilgrastim-fpgk (Stimufend), biosimilar to Neulasta, and adalilmumab-aacf (Idacio), biosimilar to Humira, according to the press release.1

  1. Fresenius Kabi’s Biosimilar Tyenne (tocilizumab-aazg) becomes the first IV and Subcutaneous tocilizumab biosimilar approved by the FDA. News release. Fresenius Kabi. March 7, 2024. Accessed March 7, 2024. https://www.fresenius-kabi.com/us/news/fresenius-kabi-s-biosimilar-tyenne-tocilizumab-aazg-becomes
  2. FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis. News release. FDA. September 29, 2023. Accessed March 7, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-biosimilar-actemra-treat-adult-and-pediatric-arthritis
  3. Prescribing Information: tocilizumab-aazg (Tyenne). Fresenius Kabi. March 7, 2024. Accessed March 7, 2024. https://www.biospecialized.com/wp-content/uploads/2024/03/Tyenne-USPI.pdf
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