The company said the biosimilar was developed, manufactured and submitted for regulatory approval by Dr. Reddy's Laboratories. The approval follows a successful Pre-License Inspection (PLI) by the USFDA at the company's biologics manufacturing facility in Bachupally, Hyderabad.
Under an existing commercialization agreement, Fresenius Kabi will hold the exclusive rights to commercialize the rituximab biosimilar in the United States.
Commenting on the development, Sridevi Khambhampaty, Global Head, Biologics, Dr. Reddy's Laboratories, said the approval demonstrates the company's capabilities in developing and manufacturing complex biologic medicines for global markets.
"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," she said.
According to the company, the rituximab biosimilar is already commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets. It has also received marketing approvals in Switzerland and Canada.
Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes and is widely used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as autoimmune disorders such as rheumatoid arthritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Dr. Reddy's said the USFDA approval was supported by 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, consistent with the regulator's biosimilar approval requirements.
The approval further expands Dr. Reddy's biosimilars business, which currently markets six biosimilar products in India, with several products also available in more than 30 countries. The company continues to advance its biosimilars pipeline in oncology and autoimmune diseases while expanding manufacturing capacity to support global launches.
The Hyderabad-based drugmaker has been steadily expanding its biologics footprint in regulated markets, including the launch of its bevacizumab biosimilar in the UK in 2024 and the commercialization of its rituximab biosimilar in Europe in 2025.
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