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.