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Alvotech Suffers Delay On Higher-Strength Adalimumab In US

Facility Inspection Obstacles Lead FDA To Defer Action On Humira Biosimilar

 
• By Dave Wallace

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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Alvotech’s biosimilar has suffered a setback due to inspection delays • Source: Alamy

Alvotech has seen a delay in US Food and Drug Administration action on its AVT02 biosimilar candidate, a proposed rival to the higher-concentration formulation of Humira (adalimumab), after obstacles preventing facility inspections led the agency to defer action on the firm’s biologics license application.

As well as seeking approval for the 100mg/ml adalimumab biosimilar, Alvotech is also pursuing an interchangeability designation for the product, recently announcing positive results from a key switching study

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