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Alvotech, Teva's Stelara Biosimilar Gets FDA Approval for New IV Presentation
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Alvotech, Teva's Stelara Biosimilar Gets FDA Approval for New IV Presentation
Oct 22, 2024 12:11 PM

07:53 AM EDT, 10/22/2024 (MT Newswires) -- Alvotech ( ALVO ) and Teva Pharmaceuticals (TEVA) said Tuesday the US Food and Drug Administration has approved a new intravenous formulation of Selarsdi, a biosimilar to Stelara, in a 130 mg/26 ml single-dose vial.

Approval of Selarsdi in new presentation expands the label to cover the treatment of adults with Crohn's disease and ulcerative colitis, the companies said.

The development comes ahead of Selarsdi's launch for all indications in the US, expected in Q1 2025.

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