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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Sandoz is looking to enter the European market for high-concentration adalimumab after announcing EMA acceptance of its filing for a 100mg/ml version of its Hyrimoz biosimilar. Celltrion and Stada/Alvotech already have higher-strength rivals to Humira available in Europe.
Alvotech and AbbVie have settled all of their legal disputes over Alvotech’s AVT02 biosimilar rival to Humira. With Alvotech seeking a coveted interchangeability designation for its higher-strength adalimumab, the firm’s US entry date provided by the settlement matches that of Boehringer Ingelheim’s interchangeable Cyltezo lower-strength adalimumab biosimilar.
While awaiting news from the FDA for its biosimilar application referencing the higher-concentration formulation of Humira, Alvotech has announced that the FDA has accepted its BLA supporting interchangeability for the AVT02 candidate.