Dr. Reddy's Laboratories has received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar version of Rituxan (rituximab), paving the way for its entry into the US market.

The approval marks another milestone in the company's expanding global biosimilars portfolio and strengthens its presence in the highly regulated US biologics market.

The biosimilar was developed, manufactured and submitted for approval entirely by Dr. Reddy's Laboratories. The approval follows a successful Pre-License Inspection (PLI) conducted by the US FDA at the company's biologics manufacturing facility in Bachupally, Hyderabad, highlighting its capabilities in developing and producing complex biologic medicines.

Under an existing commercialisation agreement, Fresenius Kabi will hold the exclusive rights to market the product 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 rituximab biosimilar is already marketed in India, the European Union, the United Kingdom, and more than 25 emerging markets. It has also received marketing approval in Switzerland and Canada.

Rituximab is a monoclonal antibody that targets the CD20 antigen found on B lymphocytes and is widely used in the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukaemia, and certain autoimmune diseases.

According to the company, the FDA approval is backed by a comprehensive package of analytical, non-clinical and clinical data demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity or potency, in line with the FDA's biosimilar approval requirements.