Tuesday, September 06, 2022
Alvotech, a global biotech company dedicated to developing and manufacturing biosimilar medicines, announced today that it has received communication from the U.S. Food and Drug Administration (FDA) regarding the assessment of the inspection conducted at Alvotech's manufacturing facility in Reykjavik, Iceland in March 2022, as well as Alvotech's subsequent written responses to the FDA.
The FDA's Complete Response Letter, in response to the initial biosimilar Biologics License Application (BLA) for AVT02, highlighted certain deficiencies related to the Reykjavik facility. The FDA stated that satisfactory resolution of these deficiencies is necessary before the BLA can be approved.
Mark Levick, Chief Executive Officer of Alvotech, expressed the company's commitment to addressing the outlined deficiencies and working closely with the FDA to conclude the facility inspection. Alvotech aims to satisfactorily resolve the issues before the Biosimilar User Fee Act (BSUFA) goal date for the interchangeable biosimilar BLA in December. Levick added, "We are dedicated to making AVT02 available to patients worldwide and anticipate being launch-ready by our expected launch date in the U.S. on July 1, 2023."