Fresenius Kabi's Tocilizumab Biosimilar, Tyenne, Launches in US Market

Fresenius Kabi announced the launch of the intravenous (IV) formulation of its tocilizumab (Actemra; Genentech) biosimilar, Tyenne (tocilizumab-aazg), in the US market.¹ The launch expands the treatment armamentarium for patients with chronic autoimmune diseases in the US.

Tyenne is the first tocilizumab biosimilar to launch in the US and was the second to be approved following Biogen and Bio-Thera Solutions' Tofidence (tocilizumab-bavi).² Tyenne is also the first tocilizumab biosimilar to be FDA approved with both IV and subcutaneous administration options, with Tofidence only approved for IV administration.

“Tyenne will impact the treatment landscape for inflammatory and immune diseases in the US,” Pierluigi Antonelli, CEO of Fresenius Kabi, said in a statement.¹ “Reaching ever more patients with our state-of-the-art biopharma portfolio signals a clear growth path in a highly promising market segment. We will continue to roll out our comprehensive pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.”

Tyenne is Fresenius Kabi’s third approved biosimilar in the US, after Stimufend (pegfilgrastim-fpgk), which was approved in September and launched in February 2023; and Idacio (adalimumab-aacf), which was approved in December 2022 and launched in July 2023.²

The FDA approved Tyenne, an IL-6 receptor antagonist referencing tocilizumab, in March of 2024 for the treatment of inflammatory and immune conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.³

“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,” Michael Schönhofen, PhD, Fresenius Kabi president, Biopharma, said in a statement following Tyenne’s approval.³ “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. 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.”

References

1. Fresenius accelerates momentum in its (Bio)Pharma business and launches Tyenne, its third approved biosimilar in the U.S. News release. Fresenius Kabi; April 15, 2024. Accessed April 16, 2024. https://www.fresenius-kabi.com/news/tyenne-third-approved-biosimilar-in-us

2. Jeremias S. FDA green lights second tocilizumab biosimilar. Center for Biosimilars. March 7, 2024. Accessed April 16, 2024.

3. 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 April 16, 2024. https://www.fresenius-kabi.com/us/news/fresenius-kabi-s-biosimilar-tyenne-tocilizumab-aazg-becomes