Dr. Reddy’s Laboratories, an Indian pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a comprehensive review of its proposed biosimilar rituximab candidate, DRL_RI.

This news comes on the heels of similar acceptance from the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

In January 2023, Dr. Reddy’s Laboratories confirmed the successful completion of the clinical studies of DRL_RI intended for submission in highly regulated markets such as the United States, the European Union, and other regions. The company submitted its dossier in April 2023, backed by robust data demonstrating similarity in pharmacokinetics, pharmacodynamics, safety, efficacy, and immunogenicity with the European Union and US reference products.

DRL_RI is a biosimilar of Rituxan/MabThera (rituximab), a cytolytic antibody aimed at the cluster of differentiation 20 (CD20). It’s approved for several indications, including adult patients’ treatment with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis, and microscopic polyangiitis.

Already approved for marketing in India and over 25 emerging markets, Dr. Reddy’s Laboratories’ rituximab biosimilar is set to expand its footprint. Currently, the pharmaceutical giant is collaborating with Fresenius Kabi, a global healthcare company specializing in biopharmaceuticals, to commercialize its proposed biosimilar of rituximab in the United States. The company also plans to directly commercialize the product in Europe and other regions.

Dr. Jayanth Sridhar — Dr. Reddy’s Laboratories Global Head of Biologics said: “This milestone underscores our capability for global clinical development of high-quality biosimilar products for highly regulated and global markets. It also reinforces the potential of DRL_RI as a safe and effective treatment option for patients across the globe.

“Development and commercialisation of biological drugs is an important growth lever for our business. We expect to bring many more biosimilar and other critical biological products to meet patient needs as we work towards our goal of serving over 1.5 billion patients by 2030.”

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