The USFDA rejected Alvotech’s application to approve its biosimilar of AbbVie’s Humira after an inspection of the company’s Reykjavik, Iceland, manufacturing plant.
Alvotech received communication from the U.S. Food and Drug Administration (USFDA) detailing its assessment of the March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland and Alvotech’s subsequent written responses to the FDA.
The FDA’s Complete Response Letter to the initial biosimilar Biologics License Application (BLA) for AVT02 noted certain deficiencies related to the Reykjavik facility and stated that satisfactory resolution of the deficiencies is required before FDA may approve this BLA.
AVT02 is a monoclonal antibody that is being evaluated for biosimilarity and interchangeability to Humira (adalimumab), which inhibits tumor necrosis factor (TNF). AVT02 has been approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada. AVT02 dossiers are under review in multiple countries, including in the United States.
“Alvotech looks forward to addressing the deficiencies outlined in the post-application action letter and continuing to work with the FDA to close out the facility inspection. We aim to satisfactorily address the issues before the Biosimilar User Fee Act (BSUFA) goal date for the interchangeable biosimilar BLA in December,” said Mark Levick, Chief Executive Officer of Alvotech. “We are committed to bringing AVT02 to patients worldwide and anticipate being launch ready by our expected launch date in the U.S. of July 1, 2023.”
