Tyenne®*, Fresenius Kabi’s Tocilizumab Biosimilar, Receives European Commission Approval

Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, announced today that the European Commission (EC) granted marketing authorization for its tocilizumab biosimilar Tyenne®, referencing RoActemra®** (tocilizumab), valid for all member states of the European Union. 

Tyenne® becomes the first tocilizumab biosimilar to be granted marketing authorization in Europe 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.

Pierluigi Antonelli, Fresenius Kabi CEO: “We are proud to be the first company to receive the marketing authorization for a tocilizumab biosimilar from the European Commission. The marketing authorization for Fresenius Kabi’s third biosimilar product in the European market is an important milestone on our pathway to consistently broadening our biopharma portfolio in the EU and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”

“Being on the cutting edge of proposing an affordable, high-quality, and safe 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. Tyenne® is our latest product in our expanding biosimilars portfolio for autoimmune and oncology related diseases, confirming our Vision 2026 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,” said Dr. Michael Schönhofen, Fresenius Kabi President Biopharma.

Fresenius Kabi received EC 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 Europe. 

Tyenne® is the company’s third biosimilar granted marketing authorization by the EC, following previous approvals of its commercially available biosimilars Idacio®*** (adalimumab) and Stimufend®**** (pegfilgrastrim). Fresenius Kabi’s growing pipeline of autoimmune and oncology biosimilars has several molecules in late-stage development.
 

About Tyenne®, a tocilizumab biosimilar 

Tyenne® (tocilizumab), is a biosimilar to the reference medicinal product RoActemra®, a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. Tocilizumab is a biological therapy approved in the EU for use in 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. 

Tyenne® demonstrates Fresenius Kabi’s commitment to providing access to affordable and cost-effective biosimilars to more patients living with autoimmune diseases around the world while enabling savings for health care systems. KabiCare, Fresenius Kabi’s comprehensive patient support program, is available to patients and health care providers from launch in Europe.