FDA Approves Second Tocilizumab Biosimilar

The US FDA approved biosimilar tocilizumab-aazg (Tyenne) by Fresenius Kabi, making it the second tocilizumab biosimilar approved. It is available in both IV and subcutaneous formulations, similar to the reference product Actemra. The approval was based on outcome and safety data from clinical studies. Common side effects include upper respiratory tract infections, headache, and injection site reactions. Serious side effects include serious infections and hepatotoxicity. Fresenius Kabi plans to launch the drug in more countries, but the availability in the US is unclear due to a patent settlement agreement with Genentech. Fabrice Romanet expressed satisfaction in being the first company to receive approval for both formulations.

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