Credit: US Food and Drug Administration

Fresenius announced the immediate availability of its tocilizumab biosimilar, tocilizumab-aazg (Tyenne), in the United States (US).¹ The drug, which is Fresenius’ third US Food and Drug Administration (FDA)-approved biosimilar available in the US, is used for the treatment of chronic autoimmune diseases, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (JIA), polyarticular juvenile idiopathic arthritis (PJIA), and giant cell arteritis.

The drug achieved FDA approval on March 5, 2024 and is the first focilizumab biosimilar with both intravenous and subcutaneous approved formulations.²

“With the launch of Tyenne in the US, we have reached another important milestone in accelerating our strong (Bio)Pharma momentum,” said Michael Sen, CEO of Fresenius, in a press release.¹ “Growing this platform is a substantial cornerstone of our #FutureFresenius journey. We are particularly happy with the good progress of our majority-owned biotechnology company mAbxience and the traction of Tyenne, the first tocilizumab biosimilar available in Europe since November 2023.”

The #FutureFresnius movement aims to help Fresenius, a global healthcare company headquartered in Germany that specializes in the therapy and care of critically and chronically ill patients, become a leading therapy-focused company, including a simplified structure to enhance performance between Fresenius Kabi and Fresenius Helios.

About Tocilizumab-aazg

Tocilizumab-aazg, an interleukin-6 (IL-6) receptor antagonist, has been approved for the treatment of several autoimmune conditions. It has currently been launched in more than 10 countries and will be available in additional countries in 2024 and 2025. It is offered in pen injector, vial, and prefilled syringe presentations.

In previous studies, serious infections leading to hospitalization or death have occurred, including opportunist infections and tuberculosis. The drug is contraindicated in patients with documented hypersensitivity to tocilizumab products.

“Offering the first FDA-approved tocilizumab biosimilar therapy option in both intravenous and subcutaneous formulations to people living with autoimmune diseases in the US is a moment of great pride for Fresenius Kabi,” Michael Schönhofen, Dr. rer. Nat,Fresenius Kabi President Biopharma, said in a statement regarding the March FDA approval.³

Previous Tocilizumab Biosimilar Approvals

The first FDA-approved tocilizumab biosimilar, tocilizumab-bavi, was introduced in September 2023 and approved for adult patients with moderate to severe active RA who had inadequate response to ≥ 1 disease-modifying antirheumatic drugs (DMARDs); patients aged ≥ 2 years with active PJIA; and patients aged ≥ 2 years with active systemic JIA.⁴

That biosimilar was approved based on findings from a randomized, double-blind, single-dose, parallel phase 1 trial data comparing the pharmacokinetics, safety and immunogenicity to both US and EU reference tocilizumab across 3 patient arms.⁴

An additional randomized, double-blind, multiple-dose, 3-arm phase 3 trial assessed the reference biologic to tocizilumab’s equivalent efficacy and comparable safety, pharmacokinetic and immunogenetic profiles in patients with RA inadequately controlled by methotrexate. Results indicated the totality of clinical and analytic evidence supported the reference biosimilar’s equivalence to tocizilumab.⁴

“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,” Schönhofen states regarding the launch of tocilizumab-aazg. “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.”³

References

1. ^{Fresenius accelerates momentum in its (bio)Pharma Business and launches Tyenne®*, its third approved biosimilar in the U.S. Tyenne: The Third Approved Biosimilar in the U.S. Accessed April 16, 2024. https://www.fresenius-kabi.com/news/tyenne-third-approved-biosimilar-in-us.}
2. ^{Pine L. FDA approves biosimilar tocilizumab-aazg for the treatment of autoimmune diseases. HCP Live. March 7, 2024. Accessed April 16, 2024. https://www.hcplive.com/view/fda-approves-biosimilar-tocilizumab-aazg-for-the-treatment-of-autoimmune-diseases.}
3. ^{Biogen. FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), a Biosimilar Referencing ACTEMRA®. Press release. Published September 29, 2023. https://investors.biogen.com/news-releases/news-release-details/fda-approves-biogens-tofidencetm-tocilizumab-bavi-biosimilar}
4. ^{Fresenius Kabi’s biosimilar Tyenne® (tocilizumab-aazg) becomes the first IV and subcutaneous tocilizumab biosimilar approved by the FDA. Fresenius Kabi USA. March 7, 2024. Accessed March 7, 2024. https://www.fresenius-kabi.com/us/news/fresenius-kabi-s-biosimilar-tyenne-tocilizumab-aazg-becomes.}