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Approval Alert: FDA Approves Alvotech & Teva’s Ustekinumab, Selarsdi™

Apr 16, 2024

On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US.

This is the second US biosimilar approved under the strategic agreement between Teva and Alvotech, following the FDA approval of Simlandi® (adalimumab) as an interchangeable biosimilar to AbbVie’s Humira® in February.

SELARSDI™ can be launched in the US from 21 February 2025, following Alvotech’s and Teva’s ustekinumab settlement with Johnson & Johnson in June 2023.