FDA raises no further objections to Alvotech facility

The U.S. Food and Drug Administration (FDA) has completed an inspection of Alvotech's manufacturing facility in Reykjavik, Iceland, with no further objections raised against the company or its production licenses. This inspection follows a previous one in November where the FDA noted ten issues, including microbial contamination and inadequate air and sterilization systems.

“

This is an important milestone for the company and reflects the significant work our employees have put into strengthening the company's quality and production systems.

Alvotech CEO Lisa Graver stated that the company's corrective actions fully addressed the FDA's previous concerns. "This is an important milestone for the company and reflects the significant work our employees have put into strengthening the company's quality and production systems," Graver said in a statement. "We continue to work with the FDA to gain approval for our market authorization applications in the United States."

“

The outcome reassures us that the actions we have taken fully address the FDA's comments from the inspection.

The November inspection had led to a delay in the market approval process for Alvotech's biosimilar drug AVT05. The company recently announced it has resubmitted applications to the FDA for AVT05, a Simponi (golimumab) biosimilar, and AVT06, an Eylea (aflibercept) biosimilar. Additionally, Alvotech reported last month that the FDA accepted for review an application for AVT16, a planned Entyvio (vedolizumab) biosimilar.

“

We continue to work with the FDA to gain approval for our market authorization applications in the United States.