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FDA Approves Biosim to Actemra – Tyenne

……. catching up on FDA approvals

The FDA recently approved another tocilizumab biosimilar, Tyenne (tocilizumab-aazg) from Fresenius Kabi, indicated for Rheumatoid arthritis, Giant cell arteritis, Polyarticular juvenile idiopathic arthritis, and Systemic juvenile idopathic arthritis. Tyenne is a biosimilar to reference product Actemra (tocilizumab).

Being the second biosimilar to be approved is normally not much news. However, this approval is unique as Tyenne was approved for both IV and subcutaneous administration. Actemra and the preceding biosimilar, Tofidence (tocilizumab-bavi), are available only in IV form. 

All the tocilizumab products carry a Black Box Warning. 

Tyenne was not approved as an interchangeable biosimilar.

CLICK HERE to access prescribing information

The US average monthly cost of IV Actemra for rheumatoid arthritis, administered intravenously, is $2,134 – $4,268 depending on dosage. Pricing for IV and/or Sub-q Tyenne were not available.

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FDA Green Lights Second Tocilizumab Biosimilar

CLICK HERE to access the press release

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