Alvotech USA, Inc. – FDA CRL

Alvotech USA Inc. received a Complete Response Letter from the FDA on November 24, 2025, regarding its Biologics License Application (BLA 761435) for AVT06. The agency determined that the application cannot be approved in its current form due to unresolved facility issues and labeling deficiencies. Specifically, the FDA identified deficiencies during a pre-approval inspection and a separate remote regulatory assessment. The company must ensure these manufacturing facilities provide satisfactory responses to the findings, and the FDA indicated that an onsite inspection may be required before approval can be granted. Additionally, the FDA requested revisions to the prescribing information and container labeling to comply with regulatory standards for format and content. These requirements are governed by the Public Health Service Act and the Code of Federal Regulations (21 CFR Parts 201 and 601). To move forward, Alvotech must submit a complete resubmission within one year that addresses all identified facility deficiencies, provides updated labeling, and includes a comprehensive safety update from all clinical and nonclinical studies. A partial response will not be accepted for review.