Alvotech remains in discussions with the US Food and Drug Administration over its proposed AVT02 biosimilar to the higher-concentration formulation of Humira (adalimumab) following a recent complete response letter noting certain deficiencies related to Alvotech’s manufacturing facility in Reykjavik, Iceland.
At the same time, the company’s partner in Australia, Cipla, has been granted a marketing authorization from the country’s Therapeutic Goods