Fresenius Kabi and Formycon receive US FDA approval for biosimilar Otulfi (ustekinumab-aauz)

Fresenius Kabi

30 September 2024 - In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has the right to market Otulfi in the US no later than 22 February 2025.

Fresenius Kabi and Formycon announced today that the US FDA has approved Otulfi™ (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara (ustekinumab).

Read Fresenius Kabi press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Biosimilar