Dr Reddy's Secures US FDA Approval for Rituximab Biosimilar, Fresenius Kabi to Commercialize
Key Insights
Dr Reddy's Laboratories received US FDA approval for its rituximab biosimilar, a monoclonal antibody targeting CD20 (search) on B lymphocytes.
Fresenius Kabi holds exclusive US commercialization rights under an agreement with Dr Reddy's.
The biosimilar is indicated for B-cell malignancies including non-Hodgkin lymphoma (search) and chronic lymphocytic leukemia (search), plus certain autoimmune conditions.
Dr Reddy's Laboratories announced on Saturday, August 1, that it has received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar version of Roche's Rituxan (rituximab), for the US market. 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 FDA 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 commercialization agreement, Fresenius Kabi will hold exclusive rights to commercialize the rituximab biosimilar in the US.
Clinical Profile and Indications
Rituximab is a monoclonal antibody that targets the CD20 (search) antigen on B lymphocytes. It is used in the treatment of several B-cell malignancies, including non-Hodgkin lymphoma (search) and chronic lymphocytic leukemia (search), 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.
Regulatory and Manufacturing Milestones
The approval follows a Pre-License Inspection conducted by the US FDA at Dr Reddy's biologics manufacturing facility in Bachupally, Hyderabad, underscoring the company's capabilities in developing and manufacturing complex biologic medicines for global markets.
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.
Global Market Footprint
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 approval in Switzerland and Canada. The US approval now adds the world's largest pharmaceutical market to this footprint.
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.
Commercial Strategy
Fresenius Kabi's exclusive US commercialization rights position the product to compete in the institutional channel, targeting hospitals, oncology clinics, and payers seeking lower-cost biologic options. The rituximab biosimilar market is competitive, with products from global players including Celltrion and Sandoz in various markets.
The partnership leverages Dr Reddy's development and manufacturing expertise alongside Fresenius Kabi's established US commercial infrastructure, aiming to broaden patient access to this important biologic therapy.