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.
You may also be interested in...
After Latest Adalimumab CRL, Alvotech Gets Another New Quality Chief
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.
What’s Next? Five Things To Look Out For In December
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.
Alvotech Reiterates Meeting US Humira Biosimilar Launch Date
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.