Alvotech Suffers Delay On Higher-Strength Adalimumab In US
Facility Inspection Obstacles Lead FDA To Defer Action On Humira Biosimilar
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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Six months after replacing its chief quality officer, biosimilars specialist Alvotech has again appointed a new head of quality, in the wake of the latest US FDA knockback for its AVT02 proposed adalimumab biosimilar rival to Humira.
In a busy final month of the year, key legal action will be heard in both the US and Europe, while the Medicines Patent Pool will hear from applicants for a milestone voluntary licensing agreement covering Novartis’ nilotinib.
Recently public Alvotech had much to share as part of its nine-month financial report, including updates on adalimumab in the US and the process to begin biosimilar golimumab trials.