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Alvotech Suffers Delay On Higher-Strength Adalimumab In US

Facility Inspection Obstacles Lead FDA To Defer Action On Humira Biosimilar

Executive Summary

Alvotech has suffered a setback in its attempt to gain the first US FDA approval for a higher-strength biosimilar adalimumab rival to Humira, after obstacles preventing facility inspections led the agency to defer action on the firm’s AVT02 candidate.

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