Alvotech and Teva win FDA approval of Stelara copy
The Icelandic-Israeli pairing of Alvotech (Nasdaq: ALVO) and Teva Pharmaceutical Industries (NYSE: TEVA) have announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use.
This follows an earlier rejection from the FDA, based on issues identified at Alvotech's Reykjavik facility.
Selarsdi is a biosimilar to Johnson & Johnson’s (NYSE: JNJ) Stelara, and has been approved for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older.
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