Dr. Reddy’s Laboratories has faced a setback in its efforts to bring its denosumab biosimilar, AVT03, to the US market. The US Food and Drug Administration (USFDA) has issued a warning letter to the company after conducting an inspection of its manufacturing facility. The inspection revealed several issues with the plant’s quality control systems, which have raised concerns about the safety and efficacy of the biosimilar.
Denosumab is a monoclonal antibody used to treat osteoporosis, bone metastases, and giant cell tumor of bone. The reference product, Prolia, is marketed by Amgen and has been a major commercial success. Dr. Reddy’s AVT03 is a biosimilar version of Prolia, which the company had hoped to launch in the US market.
The USFDA inspection, which took place in 2022, identified several issues with the plant’s quality control systems, including inadequate procedures for ensuring the sterility of the product, insufficient testing of the product’s stability, and inadequate training of personnel. The agency also found that the company had failed to investigate and correct deviations from its quality control procedures.
As a result of the inspection, the USFDA has issued a warning letter to Dr. Reddy’s, which outlines the specific issues that need to be addressed. The company must now take corrective action to address these issues and demonstrate to the agency that its quality control systems are adequate to ensure the safety and efficacy of AVT03.
The setback is a significant blow to Dr. Reddy’s, which had been hoping to launch AVT03 in the US market in the near future. The company will now need to take time to address the issues raised by the USFDA and resubmit its application for approval. This could delay the launch of AVT03 by several months or even years, depending on the complexity of the issues and the time it takes to resolve them.
The news is also a disappointment for patients who were hoping to have access to a more affordable version of denosumab. Biosimilars like AVT03 have the potential to significantly reduce the cost of biologic therapies, making them more accessible to patients who need them. However, the USFDA’s strict regulatory requirements are in place to ensure the safety and efficacy of these products, and Dr. Reddy’s must now take the necessary steps to demonstrate that AVT03 meets these standards.