The U.S. Food and Drug Administration has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older, Alvotech (ALVO) and Teva Pharmaceuticals said in a statement.
ALVO closed Tuesday's regular trading at $12.73 up $0.23 or 1.84%. In the after-hours trading the stock further gained $1.66 or 13.04%.
Under the strategic partnership between Teva and Alvotech, Teva is responsible for the exclusive commercialization of Selarsdi in the United States.
Selarsdi is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara.
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