Alvotech Reveals Action Date For Interchangeable Adalimumab BLA
FDA Has Accepted AVT02 BLA For Review Including New Data
While awaiting news from the FDA for its biosimilar application referencing the higher-concentration formulation of Humira, Alvotech has announced that the FDA has accepted its BLA supporting interchangeability for the AVT02 candidate.
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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.
Samsung Bioepis and Organon have broken new ground for Humira biosimilars in the US after receiving the first FDA approval for a higher-strength 100mg/ml adalimumab biosimilar.