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Fresenius Kabi Gets Ready To Launch Europe’s First Tocilizumab Rival

Biosimilar Version Of RoActemra Receives Formal European Commission Approval

 
• By Dave Wallace

Fresenius Kabi has celebrated the approval of Europe’s first tocilizumab biosimilar. The rival to RoActemra is expected to be launched later this year under a settlement agreement with originator Genentech.

Tocilizumab_Injections
Fresenius Kabi gets European approval for a RoActemra biosimilar

Fresenius Kabi has welcomed the formal approval by the European Commission of its Tyenne (tocilizumab) biosimilar rival to RoActemra, setting the stage for a launch that is expected later this year under a patent settlement with originator Genentech.

Key Takeaways:

  • Tyenne is the first tocilizumab biosimilar version of RoActemra approved by the European Commission

  • Fresenius Kabi received approval for the biosimilar in both subcutaneous and intravenous formulations

  • Under a patent settlement with Genentech, Fresenius Kabi will

Tyenne – which has also been filed in the US (Also see "FDA Accepts Kabi’s Actemra Biosimilar – Will It Be First?" - Generics Bulletin, 3 August, 2022.) – is Europe’s first approved tocilizumab biosimilar

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