Dr. Reddy's Laboratories Receives FDA Approval for Rituximab Biosimilar, Expanding Global Portfolio

Dr. Reddy's Laboratories Receives FDA Approval for Rituximab Biosimilar, Expanding Global Portfolio​

Dr. Reddy's Laboratories Ltd. has announced that the U.S. Food and Drug Administration (FDA) has approved its rituximab biosimilar for the U.S. market, a development that significantly strengthens the company's global biosimilars portfolio and advances its business presence in the United States.

The approval pertains to the rituximab biosimilar, which is a biosimilar to Rituxan®. The product was developed, manufactured, and submitted by Dr. Reddy's Laboratories. This milestone followed a successful Pre-License Inspection (PLI) conducted by the U.S. FDA at the company's biologics manufacturing facility located in Bachupally, Hyderabad.

Under the commercialization agreement for the United States, Fresenius Kabi has been granted the exclusive rights to market and sell the product within the U.S. pharmaceutical sector.

Global Head of Biologics at Dr. Reddy's Laboratories stated that "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."

This new approval builds upon an existing international market presence, as the rituximab biosimilar has already been commercialized in India, the European Union, the United Kingdom, and over 25 emerging markets. Furthermore, it has received marketing approval in Switzerland and Canada.

Meeting FDA Requirements​

The approval of the rituximab biosimilar by the FDA was supported by a comprehensive body of analytical, non-clinical, and clinical evidence. This extensive data demonstrated that the biosimilar is highly similar to the reference product with no clinically meaningful differences in safety, purity, or potency, meeting all established FDA requirements for biosimilar acceptance.

Rituximab itself is known as a monoclonal antibody that selectively targets the CD20 protein expressed on B-cells. It is widely utilized in treating various B-cell malignancies and autoimmune conditions. In the United States, rituximab is approved for adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA).

The company has a robust history in biologics, having invested heavily in developing its capabilities within oncology and immunology. Dr. Reddy's Laboratories has been involved in bringing complex biologic medicines to highly regulated markets through specialized manufacturing and R&D efforts.

DRREDDY Stock Price Movement​

On Friday, shares of Dr. Reddy's Laboratories Limited edged higher to close at ₹1148.10, gaining 0.06% or ₹0.70 in the session. The stock traded a volume of 1.09 million shares during the previous trading day.