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FDA Rejects Alvotech’s Stelara Biosimilar as Manufacturing Problems Continue

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cafead

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  • cafead   Oct 12, 2023 at 10:42: AM
via The FDA on Thursday denied to approve Alvotech’s AVT04, which it was proposing as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab), marking the fourth regulatory rejection for the Iceland-based company since last year.

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