Dr Reddy’s Laboratories has received approval from the US Food and Drug Administration (USFDA) for its rituximab biosimilar, expanding the company’s biosimilars portfolio in one of the world’s largest pharmaceutical markets. The product is a biosimilar to Rituxan® (rituximab) and marks another milestone in Dr. Reddy’s strategy to strengthen its presence in the global biologics segment.
The biosimilar was developed, manufactured and submitted for regulatory approval entirely by Dr Reddy’s Laboratories. The approval follows the successful completion of a Pre-License Inspection (PLI) by the USFDA at the company’s biologics manufacturing facility in Bachupally, Hyderabad, reaffirming its capabilities in developing and producing complex biologic medicines for highly regulated international markets.
Under an existing commercial agreement, Fresenius Kabi will hold the exclusive rights to market the rituximab biosimilar in the United States. The partnership is expected to improve patient access to high-quality biosimilar therapies while strengthening Dr Reddy’s position in the growing U.S. biosimilars market.
Commenting on the approval, Sridevi Khambhampaty, Global Head – Biologics, Dr Reddy’s Laboratories, said the regulatory clearance reflects the company’s strong expertise in the development and manufacturing of complex biologic medicines. She noted that the approval demonstrates Dr Reddy’s commitment to expanding access to affordable, high-quality biosimilars for patients across global markets.
The rituximab biosimilar has already been launched in India, the European Union, the United Kingdom and more than 25 emerging markets. It has also secured marketing approvals in Switzerland and Canada, highlighting its growing international acceptance.
Rituximab is a monoclonal antibody that targets the CD20 protein found on B lymphocytes. It is widely prescribed for the treatment of several blood cancers, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, as well as autoimmune diseases such as rheumatoid arthritis, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
The USFDA approval is supported by comprehensive analytical, non-clinical and clinical data demonstrating that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, effectiveness or quality, meeting all regulatory requirements for biosimilar approval.
Established in 1984, Dr Reddy’s Laboratories is a global pharmaceutical company headquartered in Hyderabad, India. The company develops and manufactures active pharmaceutical ingredients (APIs), generic medicines, branded generics, biosimilars and over-the-counter healthcare products, serving patients in major markets including the United States, India, Europe, Russia, China and Brazil.
Over the past 25 years, Dr Reddy’s has built a fully integrated biologics business with strong capabilities spanning research, development, manufacturing and commercialisation. Its biosimilars portfolio currently includes six commercial products in India, with several therapies marketed in more than 30 countries and a robust pipeline targeting oncology and autoimmune diseases. The latest USFDA approval further strengthens the company’s global biosimilars business and supports its long-term strategy of expanding access to affordable biologic therapies while driving future growth in regulated international markets.
