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Alvotech’s Latest FDA Knockback Cuts It Fine For Humira Rival

AVT02 Adalimumab Biosimilar Receives A Further CRL From US Regulator After Inspection

 
• By Dave Wallace

Alvotech has received a further complete response letter from the US FDA relating to its AVT02 proposed adalimumab biosimilar rival to Humira. The latest BsUFA goal date disclosed for the product is now just a few days ahead of a potential US launch.

28 June calendar with red pin
Alvotech’s next key date for AVT02 is 28 June • Source: Shutterstock

Alvotech has received another setback on its attempts to gain US approval for its AVT02 biosimilar rival to Humira (adalimumab), after the US Food and Drug Administration issued a complete response letter over deficiencies at the firm’s Reykjavik manufacturing facility.

This followed an earlier CRL issued by the FDA over the high-concentration 100mg/ml version of adalimumab

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