Dr Reddy's Laboratories has received US FDA approval for its rituximab biosimilar, a version of Rituxan.
The approval follows a successful inspection of its biologics manufacturing facility in Hyderabad.
Fresenius Kabi will exclusively commercialise the product in the United States.
Dr Reddy's Secures US FDA Approval for Rituximab Biosimilar, Expands Biologics Portfolio
The approval strengthens the company's biosimilars portfolio and marks another step in expanding its presence in the US pharmaceutical market
Dr Reddy's
Summary
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Dr Reddy's Laboratories has received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar, paving the way for the product's launch in the United States, the company said.
The approval strengthens the Hyderabad-based drugmaker's global biosimilars portfolio and further expands its biologics business in one of the world's largest pharmaceutical markets.
The company said the biosimilar was developed, manufactured and submitted for approval by Dr Reddy's. Under a commercialisation agreement, Fresenius Kabi will have exclusive rights to market the product in the US.
Approval Follows Successful FDA Inspection
According to the company, the approval comes after the US FDA successfully completed a Pre-License Inspection (PLI) at its biologics manufacturing facility in Bachupally, Hyderabad.
Dr Reddy's said the approval reflects its capabilities in developing and manufacturing complex biologic medicines for highly regulated markets and reinforces its long-term focus on biosimilars.
"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," Sridevi Khambhampaty, Global Head, Biologics, Dr Reddy's Laboratories, said in a release.
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Product Already Available in Several Markets
The rituximab biosimilar has already been 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.
Rituximab is a monoclonal antibody that targets the CD20 protein found on B-cells. It is used to treat several blood cancers, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as autoimmune diseases such as rheumatoid arthritis and certain forms of vasculitis.
The company said the US FDA approval was backed by analytical, non-clinical and clinical evidence showing that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity and potency, in line with the regulator's biosimilar approval standards.