Dr. Reddy’s Laboratories has received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar to Rituxan (rituximab).
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes and is widely used to treat several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as certain autoimmune conditions.
The FDA approval is supported by a comprehensive body of analytical, non-clinical and clinical evidence demonstrating that the biosimilar is highly similar to Rituxan, with no clinically meaningful differences in safety, purity and potency, in line with FDA requirements for biosimilar approval.
The approval further strengthens Dr. Reddy’s growing global biosimilars portfolio and expands its biosimilars business in the United States.
“The approval of the rituximab biosimilar on the FDA’s goal date reflects our capabilities in developing and manufacturing complex biologic medicines for global markets,” said Sridevi Khambhampaty, Global Head, Biologics, Dr. Reddy’s Laboratories.
The product was developed, manufactured and submitted for approval by Dr. Reddy’s Laboratories. The approval follows the successful completion of a Pre-License Inspection (PLI) by the US FDA at the company’s biologics manufacturing facility in Bachupally, Hyderabad.
Under a commercialization agreement, Fresenius Kabi holds the exclusive rights to commercialize the product in the United States.
The rituximab biosimilar has been commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets. It has also received marketing approval in Switzerland and Canada.
