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Alvotech, Teva Win US FDA Approval for Selarsdi Injection to Treat Severe Plaque Psoriasis, Psoriatic Arthritis
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Alvotech, Teva Win US FDA Approval for Selarsdi Injection to Treat Severe Plaque Psoriasis, Psoriatic Arthritis
Apr 16, 2024 3:18 PM

05:51 PM EDT, 04/16/2024 (MT Newswires) -- Alvotech ( ALVO ) and Teva Pharmaceuticals, an affiliate of Teva Pharmaceutical Industries ( TEVA ) said Tuesday that the US Food and Drug Administration approved Selarsdi injection for under-the-skin use to treat moderate to severe plaque psoriasis and active psoriatic arthritis in patients older than six years.

Selarsdi is a biosimilar of Stelara, according to the joint statement.

Selarsdi was developed by Alvotech ( ALVO ), and Teva holds the rights to commercialize the drug in the US, the statement added.

The approval for Selarsdi is based on results from a phase 3 study that showed equivalent efficacy and comparative safety and immunogenicity of the drug with reference product Stelara in patients with moderate to severe chronic plaque-type psoriasis.

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