Hyderabad-based Dr Reddy’s Laboratories has received approval from the US Food and Drug Administration for its rituximab biosimilar, a version of the cancer drug Rituxan, the company said in a stock exchange filing.
Fresenius Kabi will handle exclusive commercialisation of the product in the United States under an existing agreement between the two firms.
What the US FDA approval means for Dr Reddy’s
The clearance adds to Dr Reddy’s expanding biosimilars portfolio and marks its entry into the US market with this particular product, the company said. The drug was developed, manufactured and filed for approval entirely in-house by Dr Reddy’s.
The approval came after the FDA carried out a Pre-License Inspection at the company’s biologics manufacturing facility in Bachupally, on the outskirts of Hyderabad. Company officials said the outcome points to the firm’s ability to produce complex biologic medicines for stringently regulated markets such as the US.
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 of Biologics at Dr Reddy’s, said.
Where Dr Reddy’s Rituximab biosimilar is already approved
Rituximab, the reference product for the biosimilar, is a monoclonal antibody used to treat B-cell cancers such as non-Hodgkin lymphoma and chronic lymphocytic leukaemia, along with autoimmune conditions including rheumatoid arthritis.
Dr Reddy’s version of the drug has already been sold in India, the European Union and the United Kingdom, besides more than two dozen emerging markets. It has also secured marketing approval in Switzerland and Canada, and was launched in Europe last year, as per the filing.
The FDA’s decision was based on an extensive package of analytical, non-clinical and clinical data that the agency said showed no clinically meaningful differences in safety, purity or potency between the biosimilar and the original Rituxan.
Dr Reddy’s expands its global biosimilars business
Dr Reddy’s biologics division has been in operation for over two decades and currently has six biosimilar products on the market in India, some of which are sold in more than 30 other countries. The company has additional oncology and autoimmune-disease candidates in various stages of development for both developed and emerging markets, and has been adding manufacturing capacity to support the expansion.
The firm’s first biosimilar launch in the UK came in 2024, with a bevacizumab biosimilar sold under the brand Versavo. It had earlier introduced a pegfilgrastim biosimilar in the US and Europe through a partner.
About Dr Reddy’s Laboratories
Founded in 1984 and listed on the BSE, NSE, NYSE and NSE IFSC, Dr Reddy’s operates across generics, active pharmaceutical ingredients, branded generics, biosimilars and over-the-counter products, with its largest markets spanning the US, India, Russia and the CIS region, China, Brazil and Europe.
Dr Reddy’s share price
Dr Reddy’s share price was down 14.14% in the past month. Over the last 1 year, it is down 5.71%.