Fresenius Kabi has celebrated US approval for its Tyenne (tocilizumab-aazg) biosimilar rival to Actemra, noting that its version represented the “first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the US Food and Drug Administration.”
Fresenius Claims Edge With US Tocilizumab Biosimilar Approval
German Firm’s Tyenne Rival To Actemra Wins FDA Nod In Both IV And SC Presentations
Fresenius Kabi has claimed an advantage in the biosimilar tocilizumab arena after its Tyenne rival to Actemra was approved by the US FDA in both intravenous and subcutaneous formulations.
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Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
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Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.