Home Medizin FDA genehmigt zweites Tocilizumab-Biosimilar

FDA genehmigt zweites Tocilizumab-Biosimilar

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved the biosimilar Tocilizumab-aazg (Tyenne), announced Fresenius Kabi, the manufacturer of the drug, today.

This is the second Tocilizumab biosimilar approved by the regulatory authority and the first one approved in both intravenous (IV) and subcutaneous formulations available with the reference product Actemra, the company stated in a press release.

Tocilizumab-aazg is an Interleukin-6 (IL-6) receptor antagonist indicated for:

„Fresenius Kabi is the first company to receive FDA approval for both intravenous and subcutaneous formulations of its Tocilizumab biosimilar. It is available as a prefilled syringe, pen injector, and vial,“ said Fabrice Romanet, Senior Vice President of Innovation and Development at Fresenius Kabi Biopharma, in a statement.

The FDA approved the first Tocilizumab biosimilar manufactured by Biogen at the end of September 2023. It is administered through intravenous infusion.

The approval of Tocilizumab-aazg was based on efficacy and safety data from a dozen clinical studies. The medication can be administered as an intravenous formulation (20 mg/ml) or subcutaneously through a single-dose 162 mg/0.9 ml prefilled syringe or a single-dose prefilled autoinjector.

Common side effects of Tocilizumab-aazg include upper respiratory infections, headaches, high blood pressure, and injection site reactions. The most serious side effects include severe infections, gastrointestinal perforations, hepatotoxicity, and changes in certain laboratory results.

Fresenius Kabi announced that Tocilizumab-aazg has already been launched in 10 countries and plans to introduce it in additional countries in 2024 and 2025. It is unclear when Tocilizumab-aazg will be available in the United States.

„Under its patent settlement agreement with Genentech, Fresenius Kabi has a license to market its Tocilizumab products in the United States, starting with confidential licensing data,“ the company noted.

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