The approval strengthens the Hyderabad-based drugmaker’s biosimilars portfolio and marks another step in expanding its presence in the US pharmaceutical market.
The product was developed, manufactured and submitted for approval by Dr Reddy’s. The approval follows a recent Pre-License Inspection (PLI) conducted by the US FDA at the company’s biologics manufacturing facility in Bachupally, Hyderabad.
Under a commercialisation agreement, Fresenius Kabi will hold exclusive rights to commercialise the rituximab biosimilar in the US.
Sridevi Khambhampaty, Global Head, Biologics, Dr Reddy’s Laboratories, said the approval reflects the company’s capabilities in developing and manufacturing complex biologic medicines for global markets.
Rituximab is a monoclonal antibody that targets the CD20 antigen on B lymphocytes. It is used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as certain autoimmune conditions.
The FDA approval is based on analytical, non-clinical and clinical data that demonstrated the biosimilar’s similarity to the reference product, with no clinically meaningful differences in safety, purity and potency, the company said.
The rituximab biosimilar is already commercialised in India, the European Union, the United Kingdom and more than 25 emerging markets. It has also received marketing approval in Switzerland and Canada.
Dr Reddy’s has been expanding its biosimilars business, with a focus on oncology and immunology therapies. The company currently has six commercial biosimilar products marketed in India, with some products available in over 30 countries.
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First Published: Aug 1, 2026 10:46 AM IST
