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# 2nd Complete Response on Alvotech Humira Biosimilar
- URL: https://www.fdaweb.com/2nd-complete-response-on-alvotech-humira-biosimilar/
- Published: 2023-04-14T12:00:00.000Z
- Updated: 2026-09-14T18:25:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154221

FDA has issued Alvotech a complete response letter on its BLA for AVT02, a high-concentration biosimilar candidate referencing AbbVie’s Humira (adalimumab). The letter cites manufacturing deficiencies that were documented during a 3/17 reinspection of the company’s Reykjavik, Iceland facility. An earlier complete response letter was issued 9/2022 and the agency subsequently released the FDA-483 that was at the subject of that letter. The reinspection presumably was scheduled to confirm corrections made after the previous assessment.

The [FDA-483](https://www.fda.gov/media/161553/download?ref=fdaweb.com) cited 13 inspectional observations. For example, the agency took issue with the company’s procedural control to ensure that incoming materials are adequately qualified, saying that it did not investigate a “progressively increasing trend of critical quality defects” identified for incoming (redacted) materials.

The agency also cited certain manufacturing areas that were not under control for bacteria and mold. The 483 said there was an “unacceptably high number of mold recoveries in the classified rooms” used for manufacture of certain drug substance and drug products. It noted that there had been 91 and 89 microbial excursions in 2020 and 2021, respectively. “The corrective and preventive actions (CAPA) implemented due to reoccurring microbial excursions were inadequate to avoid future occurrences of similar excursions,” it said. Additionally, FDA said the company’s investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.

The company says the BLA remains under review and its user fee review action date is 6/28\. “Satisfactory outcome of the facility reinspection remains the key requirement for approval,” it adds.

AVT02 is a monoclonal antibody that Alvotech says has been approved as a biosimilar to Humira in the 27 EU member countries, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia and Saudi Arabia.