FDA CRL - Dr. Reddy's Laboratories, Inc.

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to Dr. Reddy’s Laboratories regarding their Biologics License Application (BLA 761471) for AVT03, a biosimilar product. The agency determined that the application cannot be approved in its current form, citing several deficiencies that must be addressed. A primary issue involves facility inspections, where the FDA identified deficiencies that require satisfactory responses to the associated Form 483. Additionally, the FDA requires revisions to the product's prescribing information to meet formatting and content standards, as well as updated carton and container labeling.

Under the regulatory framework of the Food, Drug, and Cosmetic Act, the FDA also determined that a Risk Evaluation and Mitigation Strategy (REMS) is mandatory. This strategy is necessary to address the risk of severe hypocalcemia in patients with advanced chronic kidney disease. Furthermore, the company must submit a comprehensive safety update that includes worldwide data and detailed reports on any adverse events or study discontinuations. To resume the approval process, Dr. Reddy’s Laboratories must provide a complete resubmission within one year that fully addresses all facility, labeling, and safety concerns. The proposed proprietary name for the product remains only conditionally accepted until all other application deficiencies are resolved.