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Alvotech's Biosimilar Drug Faces FDA Setback Due to Manufacturing Issues

Alvotech receives FDA complete response letter for AVT05 biosimilar to Simponi, citing manufacturing facility deficiencies. Company revises 2025 revenue outlook downward.

Alvotech's Biosimilar Drug Faces FDA Setback Due to Manufacturing Issues
Credit: Blue.painting, CC BY-SA 4.0 via Wikimedia Commons
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