Alvotech Bullish As Facility Deficiencies Hold Up Humira Biosimilar Again

AVT02 Higher-Concentration Adalimumab Formulation Previously Delayed

Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.

Illustration of businessman jumping over hurdle
Alvotech has a hurdle to clear • Source: Shutterstock

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