Product Description
Dr. Reddy's Laboratories received U.S. Food and Drug Administration (FDA) approval for its rituximab biosimilar, a biosimilar to Rituxan® (rituximab). 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 certain autoimmune conditions.
Commercialization Agreement
Under a commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the rituximab biosimilar product in the United States, which is described as "one of the world's most important pharmaceutical markets."
Manufacturing and Development
The product was developed, manufactured and submitted for approval by Dr. Reddy's Laboratories. The approval follows the successful recent Pre-License Inspection (PLI) conducted by the U.S. FDA at the Company's biologics manufacturing facility in Bachupally, Hyderabad.
Global Market Presence
The rituximab biosimilar has already been commercialized in India, the European Union, the United Kingdom and more than 25 emerging markets, and has also received marketing approval in Switzerland and Canada.
Regulatory Support
The FDA approval is supported by a comprehensive body of analytical, non-clinical and clinical evidence demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity and potency.
Company Biosimilars Business Context
Dr. Reddy's has over 25 years of biologics experience with a fully integrated organization with robust capabilities in development, manufacture and commercialization of biosimilar products in oncology and immunology. The company has a current portfolio of six commercial products marketed in India, with some products marketed in more than 30 other countries. The biosimilars business has a key role to play in driving both near-term and long-term growth for the company.
Management Commentary
Sridevi Khambhampaty, Global Head, Biologics, Dr. Reddy's Laboratories stated: "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."