Fresenius Kabi, an operating company of Fresenius, has announced that the U.S. Food and Drug Administration (FDA) has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories (DRL). The product is a biosimilar to Rituxan® (rituximab).

Under an exclusive commercialisation agreement, Fresenius Kabi holds the exclusive rights to market the biosimilar in the United States. Dr. Reddy's Laboratories was responsible for developing, manufacturing and submitting the product for regulatory approval.

The approval strengthens Fresenius Kabi’s biosimilars portfolio in the U.S. and expands its presence in the oncology and immunology markets. It also supports the company’s strategy of improving patient access to high-quality and more affordable biologic medicines.

Rituximab is a monoclonal antibody that targets the CD20 antigen found on B lymphocytes. It is commonly used to treat adults with several B-cell cancers, including non-Hodgkin lymphoma and chronic lymphocytic leukaemia, as well as certain autoimmune diseases.

The FDA approval is based on a totality of evidence approach, including analytical, non-clinical and clinical data. The data demonstrated that the biosimilar is highly similar to the reference medicine, Rituxan®, with no clinically meaningful differences, meeting the FDA’s requirements for biosimilar approval.

Biopharma remains a key part of Fresenius’ #FutureFresenius strategy. The company continues to build an integrated biopharma business covering research and development, manufacturing and global commercialisation. The approval of the rituximab biosimilar marks another step in expanding Fresenius Kabi’s biosimilars portfolio and supporting wider access to biologic therapies.

 

Source: businesswire.com

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