Alvotech USA, Inc. – FDA CRL

Alvotech USA Inc. has received a Complete Response Letter from the FDA regarding its Biologics License Application (BLA 761462) for the biosimilar product AVT05. The FDA determined that the application cannot be approved in its current form due to several outstanding regulatory and technical issues. The primary concerns stem from deficiencies identified during a pre-license facility inspection. The FDA requires the facility to provide satisfactory responses to these manufacturing-related findings, which may necessitate a re-inspection before the application can proceed. Additionally, the FDA identified issues with the proposed prescribing information and labeling. The company must update these documents to align with the reference product’s most recent labeling and comply with strict formatting standards for structured product labeling. Under the regulatory framework of 21 CFR Part 601, Alvotech is also required to provide a comprehensive safety update. This update must include new data from all clinical and nonclinical studies, a summary of worldwide safety experience, and detailed reports on any adverse events or study discontinuations. To advance the application, Alvotech must submit a complete resubmission within one year that fully addresses all facility, labeling, and safety deficiencies. Partial responses will not be accepted for review, and the product remains unapproved for legal marketing until these requirements are met.