06:13 AM EST, 11/03/2025 (MT Newswires) -- Alvotech ( ALVO ) said Monday that the US Food and Drug Administration has issued a complete response letter, or CRL, for Alvotech's ( ALVO ) biologics license application for AVT05, in a prefilled syringe and autoinjector as a biosimilar candidate to Simponi, an arthritis treatment.

The letter noted that certain deficiencies related to the manufacturing process must be resolved before the application for AVT05 can be approved.

As a result of the letter, Alvotech ( ALVO ) said it has lowered its 2025 revenue outlook to between $570 million and $600 million, down from its previous guidance of $600 million to $700 million.

Analysts surveyed by FactSet expect $662.3 million.

"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," said Robert Wessman, chairman and chief executive of Alvotech ( ALVO ).

Shares of the company were down over 22% in recent premarket activity Monday,

Price: 5.90, Change: -1.75, Percent Change: -22.88