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# FDA Sets BsUFA Goal Date for Alvotech’s Humira Biosimilar
- URL: https://www.fdaweb.com/fda-sets-bsufa-goal-date-for-alvotechs-humira-biosimilar/
- Published: 2022-12-11T12:00:00.000Z
- Updated: 2026-09-14T18:09:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153424

FDA has notified Iceland’s Alvotech that the new BsUFA goal decision date for the company’s BLA for AVT02, a Humira biosimilar, is 4/13\. Alvotech [says](https://investors.alvotech.com/news-releases/news-release-details/update-us-regulatory-status-avt02-alvotechs-proposed-high?ref=fdaweb.com) the notification indicated that the agency has completed its review of the BLA and confirmed that the data provided are sufficient to support a determination of interchangeability. The final approval will require a satisfactory inspection of the company’s manufacturing facility in Reykjavik, Iceland, and the company says it is working with the agency to schedule an inspection in the first quarter of this year.

Alvotech says an FDA 12/20/2022 complete response letter confirmed that the application review is complete and the key requirement for approval is the facility inspection.

AVT02 is described as a monoclonal antibody that has been approved as a Humira biosimilar in the 27 European Union member countries.