FDA Green Lights Second Tocilizumab Biosimilar

The FDA has approved Fresenius Kabi's tocilizumab biosimilar (Tyenne; tocilizumab-aazg), making it the second tocilizumab biosimilar overall and first tocilizumab biosimilar to be approved with both intravenous (IV) and subcutaneous administration options.

In September 2023, Biogen and Bio-Thera Solutions' Tofidence (tocilizumab-bavi) became the first biosimilar referencing Actemra (tocilizumab) to receive FDA approval. However, it was only approved for IV administration.

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. 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,” Michael Schönhofen, Dr rer nat, president of biopharma at Fresenius Kabi, in a statement.

Although Tyenne is already available in over 10 countries, the company stated that per its patent settlement agreement with Genentech, the maker of Actemra, Fresenius Kabi will launch Tyenne on the agreed upon license dates, which are confidential.

Tyenne was approved with 4 indications, including:

• Rheumatoid arthritis
• Giant cell arteritis
• Polyarticular juvenile idiopathic arthritis
• Systemic juvenile idopathic arthritis

“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. “With our third biosimilar approved in the U.S., the company makes a decisive difference for chronically ill patients in the country and continues on its pathway towards #FutureFresenius.”

Fresenius Kabi has also received approval for Stimufend (pegfilgrastim-fpgk) in September 2022 and Idacio (adalimumab-aacf) in December 2022. Stimufend launched in the US in February 2023, and Idacio launched in July 2023.

Tocilizumab agents are Il-6 receptor agonists. The FDA originally accepted Frsenius Kabi's biologics license application for Tyenne in August 2022.

Reference

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 March 7, 2024. https://www.fresenius-kabi.com/us/news/fresenius-kabi-s-biosimilar-tyenne-tocilizumab-aazg-becomes