The biosimilar represents a comprehensive, accessible, and high-quality treatment option for patients in the US treated with tocilizumab.
Following FDA approval, Fresenius Kabi’s tocilizumab-aazg (Tyenne) has become the first tocilizumab (Acterma) biosimilar with an intravenous (IV) and subcutaneous formulation.1
Fresenius Kabi sign / JHVEPhoto - stock.adobe.com
Tocilizumab-aazg is an interleukin-6 (IL-6) receptor antagonist, which blocks the action of IL-6, a cytokine that contributes to various inflammatory diseases.2 As such, it is approved for the treatment of several inflammatory and immune diseases such as rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. It represents a comprehensive, accessible, and high-quality treatment option for patients in the US treated with tocilizumab.1
Tyenne is the third US biosimilar from Fresenius Kabi to be approved by the FDA.
“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. The FDA’s approval of our tocilizumab biosimilar is a breakthrough in bringing high-quality, affordable, and accessible autoimmune treatment options to patients and healthcare providers,” said Michael Schönhofen, MD, president of biopharma at Fresenius Kabi.1 “We are expanding our biosimilars portfolio for immunology and oncology-related diseases, and we are committed to improving the quality of patients’ lives and lightening the burden on healthcare systems around the world.”
Tyenne is available in prefilled syringe, pen injector, and vial presentations, and has launched globally in more than 10 countries. The company plans to expand its global market further in the next 2 years.
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As per a confidential patent settlement with Genentech, the exact start date for marketing Fresenius Kabi’s tocilizumab biosimilar in the US remains undisclosed.1
With the FDA’s approval, Tyenne will join the likes of pefilgrastim-fpgk (Stimufend), a biosimilar to pegfilgrastim (Neulasta) launched in February 2023, and adalilmumab-aacf (Idacio) an adalimumab (Humira) biosimilar launched in July 2023, both as a part of the company’s immunology- and oncology-focused biosimilar portfolios.
In addition to its 3 FDA-approved biosimilars, Fresenius Kabi has a pipeline of immunology and oncology biosimilars in late-state development. Along with its plans of expansion, the approval of tocilizumab-aazg represents a landmark in the company’s Vision 2026 growth commitment to advance its impact and relevance on the health care world by implementing a wide range of business, innovation, and communication activities.3
“Fresenius Kabi is highly committed to enabling access to state-of-the-art and affordable medicines around the globe, with impact on almost 450 million patients’ lives annually. Our strong biosimilars pipeline stands exemplary for our ambitions,” said Pierluigi Antonelli, CEO of Fresenius Kabi.1 “With our third biosimilar approved in the US, the company makes a decisive difference for chronically ill patients in the country and continues on its pathway towards #FutureFresenius.”
Adverse events associated with tocilizumab-aazg include serious infections requiring hospitalization or death, including tuberculosis, bacterial, invasive, fungal, viral, and other opportunistic infections. The biosimilar is contraindicated for people with a known hypersensitivity to tocilizumab products.
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