Fresenius Kabi, a global health care company that specialises in biopharmaceuticals, clinical nutrition, medical technologies and I.V. generic drugs for critical and chronic conditions, announced today that the MHRA granted marketing authorisation for its tocilizumab biosimilar Tyenne.
Tyenne® becomes the first tocilizumab biosimilar to be granted marketing authorisation in the UK for the treatment of various inflammatory and immune mediated conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS) as well as for the treatment of COVID-19.
The drug works as a Interleukin-6 (IL-6) receptor antagonist.
“Developing an affordable, high-quality tocilizumab treatment option to health care providers and patients living with autoimmune diseases is an exciting step in our mission to provide access to alternative treatment options. said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma.
He continues: “Tyenne is our latest product in our expanding biosimilars portfolio for autoimmune and oncology related diseases, confirming our commitments for biopharmaceuticals within Fresenius Kabi. Improving the quality of patients’ lives around the world, while easing the burden on health care systems, will continue to establish us as a trustworthy and reliable partner.”
Fresenius Kabi received MHRA approval for both subcutaneous (prefilled syringe and autoinjector) and intravenous formulations which will offer a comprehensive, alternative treatment solution for health care professionals and patients treated with tocilizumab in the UK.
Tyenne is the company’s second biosimilar granted marketing authorisation by the MHRA, following the previous approval of its commercially available biosimilar adalimumab.
Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in late-stage development.