Dr Reddy's Labs proposed rituximab biosimilar application accepted for review by USFDA, EMA and MHRA

Hyderabad: Dr. Reddy’s Laboratories Ltd., a global pharmaceutical company, has announced that its Biologics License Application (BLA) for its proposed biosimilar rituximab candidate DRL_RI has been accepted for a substantive review by the U.S. Food and Drug Administration (USFDA).

This closely follows acceptance of its rituximab biosimilar dossier for review by two other regulatory agencies – the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA).

In January 2023, Dr. Reddy’s had announced the successful completion of the full set of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets such as the United States, European Union, and other regions. The submission of its dossier in April 2023 was based on a comprehensive data package including robust structural and functional analytical comparison data using multiple orthogonal techniques, pre-clinical, and head-to-head clinical studies that demonstrate similarity in pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity with the EU* and U.S.** reference products.

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

Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, 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.”

Dr. Reddy’s rituximab biosimilar has already been approved for marketing in India and over 25 emerging markets. The company is currently collaborating with its partner Fresenius Kabi, a global health care company that specializes in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs for critical and chronic conditions, to commercialise its proposed biosimilar of rituximab in the United States. The company intends to commercialise the product in Europe and other geographies directly.

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