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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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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 Humira Settlement Sets Up Interchangeable Adalimumab Showdown

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.

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