Alvotech (NASDAQ:ALVO) recently faced a reinspection at its Iceland facility, where FDA inspectors highlighted a potential violation. Despite this setback, the company maintains optimism about obtaining approvals for biosimilars of Stelara and Humira by the respective decision goal dates.

An FDA Form 483, stemming from the inspection, prompted the company to formulate a response in the coming days. Alvotech emphasized that only one potential violation was observed during the inspection.

Robert Wessman, Chairman and CEO of Alvotech, assured stakeholders that the identified observation is “readily addressable,” and the company is committed to providing a swift response. Alvotech remains resolute in its belief that it can secure FDA approval for AVT02 by February 24 and AVT04 by April 16, aligning with their respective goal dates.

It’s worth noting that AVT04 is a biosimilar of Johnson & Johnson’s (JNJ) Stelara, while AVT02 is a biosimilar of Abbvie’s (ABBV) Humira.

Per the FDA’s website, a Form 483 is issued at the conclusion of an inspection when investigators believe they have observed conditions that may constitute violations of the Food Drug and Cosmetic Act and related Acts.