The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. The FDA did not identify any other deficiencies with the application. The facility remains FDA approved to manufacture and continues supplying currently commercialized products.

“While we are disappointed in receiving the CRL, we expect to resolve any outstanding issues and will continue to work with the FDA to bring this first-to-market biosimilar to patients in the US,” says Robert Wessman, Chairman and CEO of Alvotech.

Reevaluated its outlook for 2025

Following the receipt of the CRL, Alvotech has reevaluated its outlook for 2025. Total revenues in 2025 are now expected to be USD 570- USD 600 million and adjusted EBITDA USD 130- USD 150 million, lower than previously provided. The lowered adjusted EBITDA outlook is primarily driven by expected continuation of investments related to resolving certain facility issues, which also require a temporary slowdown in production. These investments, however, also serve to support Alvotech’s future growth plans and new product launches, it states.