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

The approval marks another significant milestone in the company's global biosimilars strategy and further strengthens its presence in one of the world's largest and most competitive biologics markets.

Rituximab is a monoclonal antibody that targets the CD20 antigen found on B lymphocytes and is widely used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as certain autoimmune disorders.

The biosimilar was developed, manufactured and submitted for regulatory approval by Dr Reddy's Laboratories, highlighting the company's growing expertise in the development of complex biologic medicines.

The approval follows a successful Pre-License Inspection (PLI) by the US FDA at Dr Reddy's biologics manufacturing facility in Bachupally, Hyderabad, underscoring the company's compliance with stringent global quality and manufacturing standards.

Under an existing commercialization agreement, Fresenius Kabi will hold the exclusive rights to market the rituximab biosimilar in the United States.

Commenting on the milestone, Sridevi Khambhampaty, Global Head – Biologics, Dr Reddy's Laboratories, said, "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."

The rituximab biosimilar has already been commercialised in India, the European Union, the United Kingdom and more than 25 emerging markets. In addition, it has secured marketing approvals in Switzerland and Canada, reflecting its growing international footprint.

The latest US FDA approval reinforces Dr Reddy's commitment to expanding patient access to affordable, high-quality biologic therapies while strengthening its position as a global player in the biosimilars segment.