Sandoz Inc – FDA CRL

The FDA issued a Complete Response Letter to Sandoz Inc. regarding Biologics License Application (BLA) 761271, stating that the application cannot be approved in its current form. The primary obstacle to approval involves deficiencies identified during a pre-license inspection of the drug product manufacturing facility. While specific inspection dates were not provided in the document, the FDA noted that a Form 483 was issued, and the facility must provide satisfactory responses to these findings. Additionally, the FDA requires a comprehensive safety update including new data from all clinical and nonclinical studies. This update must compare the biosimilar product’s safety profile to the U.S.-licensed reference product, incorporate updated exposure information, and summarize worldwide safety experience. The agency has reserved comments on prescribing information and labeling until the other deficiencies are resolved. Under the regulatory framework of 21 CFR 601.3(b), Sandoz must resubmit the application with all required information or request an extension within one year. Failure to take action may lead the FDA to consider the application withdrawn.