FDA approves second tocilizumab biosimilar; first available in IV, subcutaneous forms
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Key takeaways:
- Tyenne (tocilizumab-aazg) is available in a prefilled syringe, pen injector or vial.
- The biosimilar will launch in “many more countries” by 2025.
The FDA has approved Tyenne, the second tocilizumab biosimilar overall and the first available in both intravenous and subcutaneous formulations, according to a press release from its manufacturer.
Tyenne (tocilizumab-aazg, Fresenius Kabi) was approved for treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. The interleukin-6 receptor antagonist is available in a prefilled syringe, pen injector or vial, according to the release from 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, PhD, president of biopharma at Fresenius Kabi, said in the release. “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 health care systems around the world.”
The approval of Tyenne follows a similar announcement in October 2023 marking Tofidence (tocilizumab-bavi, Biogen) as the first biosimilar for tocilizumab (Actemra, Genentech) to be approved by the FDA.
Tyenne is currently available in 10 countries and is set to launch in “many more countries between 2024 and 2025,” according to the release.
“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,” Fresenius Kabi CEO Pierluigi Antonelli said in the release. “Our strong biosimilars pipeline stands exemplary for our ambitions. With our third biosimilar approved in the U.S., the company makes a decisive difference for chronically ill patients.”
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